Over-the-Counter (OTC) is a world leader in the research, development, production and marketing of self-medication products that do not require prescriptions. Our products are designed for the in-home treatment and prevention of medical conditions and ailments as well as the enhancement of overall health and well-being.
The main OTC product categories are analgesics, cough, cold, allergy, gastrointestinal, skin care and smoking-cessation treatments, as well as mineral supplements.
Fungal infections of the skin
LAMISIL® 1% CREAM
Topical antifungal agent. Terbinafine as hydrochloride (10 mg/1 g cream).
Fungal infections of the skin including dermatophytoses and yeast infections; pityriasis versicolor.
Tinea pedis, cruris and corporis: 1 week, once daily; cutaneous candidiasis: 1 week, once or twice daily; Pityriasis versicolor: 2 weeks, once or twice daily.
Apply to the affected skin and surrounding area.
Known hypersensitivity to terbinafine or any of the excipients contained in the cream.
Not for use in children aged under 12 years. For external use only. Contact with the eyes to be avoided. Use in pregnancy not recommended unless clearly necessary. Avoid breast-feeding and contact of infants with any treated skin, including breast area.
No known drug interactions.
Redness, itching or stinging may occur at the site of application. Very rare: allergic reactions such as pruritus, rash, bullous eruptions and hives.
Lamisil® Cream Information version dated 29 June 2005
Nicotinell Patch (nicotine)
Unique nicotine replacement therapy
NICOTINELL® TRANSDERMAL PATCH
Nicotinell 7 mg/24 hours transdermal patch: each 10 cm2 patch contains 17.5 mg nicotine.
Nicotinell 14 mg/24 hours transdermal patch: each 20 cm2 patch contains 35.0 mg nicotine.
Nicotinell 21 mg/24 hours transdermal patch: each 30 cm2 patch contains 52.5 mg of nicotine.
Relief of nicotine withdrawal symptoms in nicotine dependency as an aid to smoking cessation. Patient counseling and support usually improve the success rate.
For adults: the degree of nicotine dependence is assessed by the number of cigarettes smoked daily, or by the Fagerström's Test for Nicotine Dependence.
|Indication||Initial phase 3 to 4 weeks||Treatment follow-up 3 to 4 weeks|
|Score of 5 or more on Fagerström's test or Smokers of 20 or more cigarettes/day||Nicotinell 21 mg/24 h||Nicotinell 14 mg/24 h or Nicotinell 21 mg/24 h||Nicotinell 7 mg/24 h or Nicotinell 14 mg/24 h then Nicotinell 7 mg/24 h|
|Score of less than 5 on Fagerström's test or Smokers of less than 20 cigarettes/day||Nicotinell 14 mg/24 h or increase to Nicotinell 21 mg/24 h||Nicotinell 7 mg/24 h or Nicotinell 14 mg/24 h||Treatment discontinuation or Nicotinell 7 mg/24 h|
Non-smoker or occasional smoker. Hypersensitivity to nicotine or any of the excipients.
In patients with recent myocardial infarction, unstable or worsening angina pectoris, severe cardiac arrhythmias, uncontrolled hypertension or recent cerebrovascular accident, use only if non-pharmacological interventions fail. Use with caution recommended in patients with severe hypertension, stable angina pectoris, cerebrovascular disease, occlusive peripheral arterial disease, heart failure, diabetes mellitus, hyperthyroidism, pheochromocytoma, severe hepatic and renal impairment, active peptic ulcer. Remove the patch prior to undergoing MRI. Pregnancy: Smoking cessation in pregnancy is recommended without nicotine substitution. However, the risk for the fetus is probably less with the patch than with smoking. Use with caution after the sixth month of pregnancy if smoking cessation has failed. Breast-feeding: Not recommended unless clearly needed.
Smoking cessation may cause increased plasma levels of narrow therapeutic window drugs metabolized by CYP1A2, e.g. theophylline, ropinirole, clozapine, olanzapine. Smoking and/or nicotine may lead to reduced effect of nifedipine or adrenergic antagonists and to increased effect of adrenergic agonists, and to reduced effects of opioids, furosemide, beta-adrenergic blockers (e.g. propranolol) and H2-antagonists (in ulcer healing). Increased subcutaneous absorption of insulin which occurs upon smoking cessation may necessitate a reduction in insulin dose.
Very common (>10%): Headache, skin reactions at the application site (burning, edema, erythema, irritation, pruritus, rash, urticaria, vesicles)
Common (1 to 10%): insomnia, abnormal dreams, nervousness, anxiety, dizziness, cough, nausea, abdominal pain, dyspepsia, myalgia, motor dysfunction.
Less frequent (<1%) but (potentially) serious: generalized allergic reactions including urticaria generalized, angioneurotic edema, and anaphylactoid reaction, attention disorder, somnolence, irritability, depressed mood, confusion, paraesthesia, abnormal taste, vision blurred, tremor, palpitations, chest pain, dyspnea, arrhythmia, hypertension, hot flush, vomiting, constipation, diarrhea, flatulence, dry mouth, hyperhidrosis, skin discoloration, cutaneous vasculitis, arthralgia, muscle cramp, asthenia, pain, discomfort.
Nicotinell® Transdermal Patch Basic Succinct Statement version dated 25 June 2008
Nicotinell Chewing Gum (nicotine)
Unique nicotine replacement therapy
NICOTINELL® FRUIT/MINT 2 MG AND 4 MG CHEWING GUMS
Nicotinell® Chewing gum contains nicotine, which is one of the substances contained in tobacco. When chewed, nicotine is released slowly and absorbed through the lining of the mouth. This nicotine replacement alleviates some of the unpleasant withdrawal symptoms often experienced when giving up smoking, such as feeling ill and irritable.
Nicotinell® Chewing gum can also reduce your desire to smoke by providing some of the nicotine previously provided from cigarettes and therefore helps your willpower to resist smoking.
Nicotinell® chewing gum is less harmful than smoking because your mouth and lungs will not be exposed to all the other harmful substances present in tobacco smoke, such as tar.
Each piece of Nicotinell® Fruit 2mg chewing gum, Nicotinell® Mint 2mg chewing gum contains 10 mg nicotine – polacrilin (1:4) equivalent to 2 mg Nicotine.
Each piece of Nicotinell® Fruit 4mg Chewing gum, Nicotinell® Mint 4 mg Chewing gum contains 20 mg nicotine – polacrilin (1:4) equivalent to 4 mg Nicotine.
Other ingredients: gum base, sorbitol (0.16g per piece), calcium carbonate, purified water, glycerol, sodium carbonate anhydrous, sodium bicarbonate, amberlite, butylated hydoxytoluene, saccharin, acesulfame potassium, sodium saccharine, talcum powder, carnauba wax and menthol.
Fruit flavor contains in addition fruit flavoring. Mint flavor contains instead of fruit flavoring, peppermint and eucalyptus.
Nicotinell® Chewing gum is sugar-free.
Nicotinell Chewing gum alleviates withdrawal symptoms in connection with smoking cessation.
You should not use Nicotinell® Chewing gum if you:
- are sensitive (allergic) to any of the ingredients of the gum are in the immediate recovery period after a myocardial infarction (heart attack)
- suffer from heart disease e.g. worsening or unstable angina, Prinzmetals angina or severe abnormalities in heart beat rhythm
- have recently suffered a stroke
- are a non-smoker
- are under 18 years of age
You should ask your doctor BEFORE you use Nicotinell Chewing gum if you:
- suffer from high blood pressure or circulatory problems
- suffer from heart disease e.g. worsening or unstable angina, Prinzmetals angina or severe abnormalities in heart beat rhythm
- have had a stroke
- have an overactive thyroid gland
- are a diabetic
- are unable to tolerate fructose
- suffer from overactive adrenal glands (phaeochromocytoma)
- have kidney or liver disease
- are taking any medicines which have been prescribed for you by your doctor.
With certain medicines your doctor may want to adjust the dose when you stop smoking.
If you suffer from esophagitis, inflammation in the mouth and throat, gastritis or peptic ulcer swallowing nicotine may make the symptoms worse.
Some denture wearers may possibly have difficulty in chewing the gum. If you do, you are recommended to use other types of nicotine replacement products. You should ask your pharmacist for advice.
To improve your chances of quitting smoking you should stop smoking cigarettes when you start to use the gum. Attending counseling sessions may also help you succeed in giving up smoking.
If you are pregnant or breast-feeding
In pregnancy the aim should be to stop smoking by the sixth month as continued smoking late in pregnancy may harm your baby or even result in premature or stillbirth. In pregnancy you should aim at stopping smoking without using nicotine replacement preparations. Joining a smoking cessation program or class may help you to achieve this. However if you are unable to stop smoking without the use of Nicotine replacement preparations, you should discuss it with your doctor.
Nicotinell chewing gum like smoking itself should be avoided during breast feeding as nicotine may be found in breast milk. If you have been unable to stop smoking, Nicotinell Chewing gum should only be used during breast feeding on your doctor’s advice.
There is no evidence of risk associated with driving or operating machinery if Nicotinell® Chewing gum is taken according to the recommended dose but remember that smoking cessation can cause behavioral changes.
The appropriate dose will depend on your previous smoking habits. In the case of heavy smoking, i.e. more than 25 cigarettes a day, 4mg nicotine Chewing gum should be considered, otherwise, 2mg nicotine Chewing gum should be used.
Increasing to the 4 mg Chewing gum may also be considered if you fail to stop smoking with the 2 mg Chewing gum or if your withdrawal symptoms remain so strong as to threaten relapse.
Acidic beverages (soda and coffee) may decrease the absorption of nicotine and should be avoided for 15 minutes prior to chewing the gum.
Instructions for use:
1. One piece of gum should be chewed until the taste becomes strong
2. The Chewing gum should then be rested between the gum and the check
3. When the taste fades, chewing should commence again
4. The chewing routine should be repeated for 30 minutes
You should take 1 piece of Chewing gum of when you feel the urge to smoke In general one piece of Chewing gum should be chewed usually every one or two hours. Normally 8-12 pieces per day are sufficient. If the user still experiences an urge to smoke, this dosage can be supplemented with additional pieces of Chewing gum, up to a maximum of 25 pieces a day of 2 mg gum or 15 pieces per day of 4 mg gum per day. The treatment time is individual but should usually be at least 3 months. Whereafter the number of pieces of gum used a day should be gradually reduced.
Treatment should be discontinued when the dose has been reduced to 1-2 pieces of gum per day. Use of Nicotinell chewing gum beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the chewing gum for longer to avoid returning to smoking.
If you chew too much, you may experience the same symptoms as if you had smoked too much. The general symptoms of nicotine overdosage include muscle weakness, sweating, increased production of saliva, throatburn, heartburn, nausea, vomiting, diarrhea, palpitations, a widening of the pupils, dizziness, and circulatory problems.
Please consult your doctor concerning the treatment of any such symptoms.
The most common side effects are dizziness, headaches, hiccups, stomach trouble such as nausea, vomiting, indigestion and heartburn, increased salivation and irritation of the mouth and throat. The gum can stick to and very rarely damage dentures and other dental work. Sometimes some of these effects could also be the withdrawal symptoms associated with giving up smoking. Less common side effects are palpitations and rashes.
Very rarely abnormalities in heart beat rhythm and allergic reactions may occur. Chewing the gum correctly may eliminate some side effects.
Nicotinell® Chewing Gum Patient Information Leaflet version dated 11 April 2011
Orofar-L (benzoxonium Cl + lidocaine HCl)
Infections in the mouth & throat
OROFAR LOZENGES / OROFAR-L GARGLE SOLUTION
Orofar Lozenges: benzoxonium chloride 1 mg + lidocaine hydrochloride 1 mg
Orofar Solution: benzoxonium chloride 0.5 mg/ml + lidocaine hydrochloride 0.5 mg/ml
Orofar contains an anti-infective and a local anesthetic to combat the bacteria, virus and fungi which cause sore throat and infections of the mouth and throat; sore throat associated with colds, pharyngitis or laryngitis (with or without difficulties in swallowing), small mouth ulcers (aphthae) and inflamed gums. Orofar can also be used as supportive treatment in tonsillitis.
Orofar Solution is also recommended for the treatment of dental plaque.
Orofar does not irritate the mouth and throat.
Hypersensitivity to products containing quaternary ammonium compounds or lidocaine. Orofar is not recommended for children less than four years old. If sore throat is accompanied by high fever, or if it persists for more than 5 days, consult your doctor.
Orofar Lozenges should not be chewed or swallowed. It should not be taken while or just prior to eating, in order to avoid swallowing the wrong way because of the local anesthetic effect of lidocaine. If Orofar Solution is used for more than two weeks, a reversible brown coloration of the tongue or the teeth may appear. This color disappears on stopping the treatment.
Advice for diabetics: The lozenges are sweetened by saccharine and Sorbitol, and do not cause dental caries. Ten lozenges are equal to one fruit ration Pregnancy and breast-feeding: If you are pregnant or breast-feeding, you must consult your doctor or pharmacist for advice before taking any medication.
Lozenges: Let one lozenge melt in your mouth every two to three hours. If needed, increase to one lozenge every one to two hours. Do not take more than ten lozenges a day. Aphthous ulcers: allow the lozenge to dissolve slowly in contact with the lesion.
Solution (mouthwash/gargle with measuring cup): Each morning and evening, after meals, gargle in the back of the mouth or rinse the mouth for 30 to 60 seconds with 15 ml of undiluted solution. Do not swallow. If a continuous treatment is needed, as with sore throat, the solution may be used more often or be replaced by the lozenges during the day. The solution is especially recommended for daily oral care, for treatment of dental plaque, gingivitis or parodontitis. Wash and dry the graduated cup after each use and between different users.
Children: Orofar may be given to children starting from 4 years of age, but the dose should be reduced. Do not give more than six lozenges a day. Spray only two to three times at each application. A 5 ml of solution is enough to rinse the mouth
In case of accidental ingestion of a large quantity of solution, tell your doctor or your pharmacist immediately. Consult your doctor or pharmacist if you have the impression that the effect of the medicine is too weak, or on the contrary, too strong.
Possible Side Effects:
If you notice any of the following side effects, stop using Orofar and tell your doctor or pharmacist immediately: In certain cases a slight local transient irritation may occur. In very rare cases, allergic reactions such as skin rash or swelling of the mouth/throat may appear.
Also tell your doctor or pharmacist if you notice any other unwanted effect which you think may be related to the use of Orofar.
Orofar® Lozenges, Gelsolets, Oromucosal Spray and Solution Core Patient Information Leaflet version dated 24 June 2011
Relief of nasal congestion due to colds, hay fever or other allergic rhinitis & sinusitis
OTRIVIN 0.1% METERED-DOSE SPRAY
Otrivin 0.1% nasal solution contains 1 mg/ml of xylometazoline hydrochloride. Each metered-dose spray delivers 0.14 mg of xylometazoline.
Otrivin 0.1% is indicated in adults and in adolescents over 12 years of age:
For the relief of nasal congestion due to colds, hay fever or other allergic rhinitis, sinusitis.
To aid drainage of secretions in affections of the paranasal sinuses.
As an adjuvant in otitis media, to decongest the nasopharyngeal mucosa.
To facilitate rhinoscopy.
Otrivin 0.1% should not be used in children aged less than 12 years old.
Before using for the first time, prime the pump by performing a few pumping motions until an even spray is released into the air. At subsequent applications the dosing spray pump will be ready for instant use.
1 spray into each nostril, 3 times daily. Leave an interval of 8 to 10 hours between doses. Do not exceed a maximum of 3 applications daily into each nostril.
Method of administration:
Be careful not to spray in the eyes.
1. Clear the nose.
2. Hold the bottle upright with thumb under base and nozzle between two fingers.
3. Lean forward slightly and insert the nozzle into a nostril.
4. Spray and breathe in gently through the nose at the same time.
5. Clean and dry the nozzle before replacing back the cap right after use.
6. To avoid possible spread of infection, the spray should only be used by one person.
Hypersensitivity to xylometazoline or to any of the excipients.
Like other vasoconstrictors, Otrivin should not be used in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.
Patients with narrow angle glaucoma.
Otrivin, like other sympathomimetic agents, should be used with caution in patients showing a strong reaction to adrenergic substances, as manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.
Like other topical vasoconstrictors, Otrivin should not be used for more than ten consecutive days: prolonged or excessive use may cause rebound congestion.
Do not exceed the recommended dose, especially in children and in the elderly.
Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism, or diabetes mellitus.
Common: Nausea , headache, nasal dryness or discomfort, application site burning.
Very rare: Hypersensitivity reaction (angioedema, rash, pruritus), transient visual impairment, irregular heart rate and increased heart rate.
Otrivin Regular (F.2), Moisturising (F.5), Preservative-Free (F.3), Menthol (F.4), Menthol Preservative-Free (F.6) Core Data Sheet version dated 24 June 2011
Sinecod Forte (butamirate citrate)
Acute cough of any etiology
SINECOD® FORTE SUSTAINED-RELEASE TABLET / SYRUP
One Sinecod teaspoonful (5 ml) of syrup contains 7.5 mg of Butamirate citrate
One Sinecod modified release film coated tablet contains 50 mg of Butamirate citrate
Symptomatic treatment of cough of various origins.
Children 3 to 6 years of age: 5 mL 3 times daily; 6 to 12 years: 10 mL 3 times daily.
Adolescents: 15 mL 3 times daily. Adults: 15 mL 4 times daily.
Modified release film coated tablets 50 mg
Adolescents over 12 years of age: 1 or 2 tablets daily.
Adults: 2 or 3 tablets daily at 8 or 12 hour intervals. To be swallowed whole.
Known hypersensitivity to any of the ingredients.
Due to inhibition of the cough reflex by butamirate, the simultaneous administration of expectorants has to be avoided, because it may lead to the stagnation of mucus in the respiratory tract, which increases the risk of bronchospasm and airways infection.
Sinecod may cause somnolence. Caution should therefore be observed while driving or performing other tasks requiring alertness (e.g. operating machines).
A doctor or pharmacist needs to be consulted if the cough persists for more than 7 days.
The use of Sinecod should be avoided during the first three months of pregnancy. During the rest of pregnancy, Sinecod should be used only if drug therapy is essential. For safety reasons, as a general rule, the benefits and risks of taking Sinecod during lactation should be carefully considered.
Somnolence, nausea, diarrhea, and urticaria rarely occurs with the use of Sinecod Forte.
Sinecod® Core Summary of Product Characteristics version dated 12 June 2009
Sinecod EXP (ambroxol HCl)
Treatment of respiratory disorders associated with wet (productive) cough
Sinecod EXP 30 mg Tablet: Each tablet contains 30 mg Ambroxol.
Sinecod EXP 30 mg/5 mL Adult Syrup: Each 5 mL contains 30 mg Ambroxol.
Sinecod EXP 15mg/ mL Pedia Syrup: Each 5 mL contains 15 mg Ambroxol.
Sinecod EXP 6 mg/mL Pedia Drops: Each mL contains 6 mg Ambroxol.
Treatment of respiratory disorders associated with viscid or excessive mucus.
Unless otherwise prescribed by a physician:
30 mg Tablet
Adults and children over 12 years old: 1 tablet 3 times a day
30 mg/5 mL Adult Syrup.
Adults and children over 12 years old: 10 mL (2 tsps) 2 times daily
15mg/ mL Pedia Syrup.
Children 7 to 12 years old: 5 mL (1 tsp) 2-3 times daily
Children 3 to 6 years old: 2.5 mL (1/2 tsp) 3 times daily
Children 1 to 2 years old: 2.5 mL (1/2 tsp) 2 times daily
6 mg/mL Pedia Drops
3 – 6 months: 0.5 mL twice daily or 6 mg/day
7 – 12 months: 1 mL twice daily or 12 mg/day
13-24 months: 1.25 mL twice daily or 15 mg/day
Should be taken immediately after meals. Pedia Drops should be used under the supervision of a physician.
Patients with history of hypersensitivity to Ambroxol or Bromhexine.
Should be given with care to patients with history of peptic ulceration. Use is not recommended in pregnant and breastfeeding mothers.
Antibiotic concentrations (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and in the sputum are increased.
Occasional or mild gastrointestinal irritation and discomfort (diarrhea, abdominal fullness, nausea) may occur. Allergic reactions, primarily skin rashes, occur rarely.
Sinecod® EXP Common Patient Information Leaflet
Varemoid Forte (hydroxyethylrutoside)
Treatment of acute hemorrhoidal conditions
VAREMOID® FORTE 200 mg Sugar-Coated Tablet
Each sugar-coated tablet contains 200 mg Hydroxyethylrutoside or Vitamin P4 factor, a unique scientific ingredient for the treatment of hemorrhoids.
Varemoid can shrink haemorrhoids, relieve swelling and inflammation, soothe pain and itch, stop bleeding and repair injured tissues.
All acute hemorrhoidal conditions including internal and external hemorrhoids and hemorrhoids of pregnancy (from the fourth month).
Initial: 1 tablet 3 times daily for one week
Maintenance: 1 tablet 2 times a day for 2-3 weeks
The tablets are to be taken with the main meals of the day.
None known to date. Varemoid is well tolerated.
Varemoid® Forte Patient Information Leaflet
Voltaren Emulgel (diclofenac)
Relief of muscle and body pains and inflammation
VOLTAREN® 1.16% EMULGEL
Oily emulsion in an aqueous gel, containing 1.16% diclofenac diethylamine (corresponding to 1% diclofenac sodium).
Post-traumatic inflammation of the tendons, ligaments, and joints, e.g. due to sprains, strains, and bruises. Localised forms of soft-tissue rheumatism, e.g. tendovaginitis, bursitis, shoulder-hand syndrome, and periarthropathy. Localised forms of degenerative rheumatism, e.g. osteoarthrosis of the peripheral joints and vertebral column.
Voltaren® Emulgel® is applied locally to the skin 3 or 4 times daily and rubbed in gently. For example, 2 to 4 g Voltaren Emulgel (cherry- to walnut-sized mass) are sufficient to treat an area of about 400 to 800 cm².
Hypersensitivity to diclofenac or to any of the excipients. Known hypersensitivity to acetylsalicylic acid (aspirin) or to other non-steroidal anti-inflammatory drugs. Third trimester of pregnancy.
Do not apply to diseased skin, open wounds or injuries. Avoid contact with the eyes and mucous membranes. Do not take by mouth. Do not use with occlusive dressing. Systemic side effects cannot be excluded when the product is applied to large areas of skin for prolonged periods of time. Avoid use during pregnancy.
Common are rash, eczema, erythema, dermatitis (including dermatitis contact), pruritus.
Rare to very rare are dermatitis bullous, rash pustular, hypersensitivity (including urticaria), asthma, photosensitivity reaction, angioneurotic edema.
Voltaren® Emulgel® Basic Succinct Statement version dated 25 January 2010
CATAFLAM® 25 mg SUGAR-COATED TABLET
Each sugar-coated tablet contains 25 mg diclofenac potassium.
Short-term treatment in the following acute conditions:
Post-traumatic and post-operative pain, inflammation and swelling, e.g. due to sprains or following dental or orthopedic surgery. Painful and/or inflammatory conditions in gynecology, e.g. primary dysmenorrhea or adnexitis. Migraine attacks. Painful syndromes of the vertebral column, non-articular rheumatism. As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.
Dose to be individually adjusted, lowest effective dose to be given for the shortest duration.
Adults: 50 to 150 mg/day in divided doses (dysmenorrhea and migraine attacks: up to 200 mg/day).
Adolescents over 14 years: 75 to 100 mg/day, with maximum daily dose of 150 mg. Children over 1 year and adolescents: 0.5 to 2 mg/kg/day, with a maximum daily dose of 150 mg.
Active gastric or intestinal ulcer, bleeding or perforation; known hypersensitivity to diclofenac or to any of the excipients, to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs); last trimester of pregnancy; severe hepatic, renal or cardiac failure.
Avoid use with other systemic NSAIDs including COX-2 inhibitors. Risks of gastrointestinal (GI) bleeding, perforation or serious allergic reactions; to be discontinued if these conditions occur. Risk of allergic reactions. May mask signs and symptoms of infection. Caution recommended in patients with symptoms/history of GI disease, asthma, seasonal allergic rhinitis, chronic pulmonary diseases, elderly or impaired hepatic function (including porphyria), ulcerative colitis or Crohn’s disease. Caution when used concomitantly with corticosteroids, anticoagulants, anti-platelets agents or SSRIs.
Caution when driving or using machines. Should not be used in the first and second trimester of pregnancy and by breast-feeding mothers. Not recommended to use in women attempting to conceive as it may impair female fertility. Combined use with protective agents to be considered in patients with history of ulcer, elderly, and those requiring low dose aspirin. Monitoring of liver function and blood counts recommended during prolonged treatment. Monitoring of renal function recommended in patients with history of hypertension, impaired cardiac or renal function, extracellular volume depletion, the elderly, patients treated with diuretics or drugs that impact renal function. Monitoring recommended in patients with defect of hemostasis. Beware of severe fluid retention and edema.
Caution with concomitant use of diuretics and antihypertensives (e.g. beta blockers, ACE inhibitors), methotrexate, other NSAIDs and corticosteroids, SSRIs. Monitoring recommended for patients receiving anticoagulants, anti-platelets agents as well as blood glucose level if used concomitantly with antidiabetics. Monitoring of serum lithium or digoxin levels recommended if used concomitantly. Dose of diclofenac to be reduced in patients receiving ciclosporin. Interactions with concomitant use of quinolone antibacterials, CYP2C9 inhibitors (e.g. sulfinpyrazone, voriconazole). Monitoring of phenytoin plasma concentrations is recommended if used concomitantly.
Common undesirable effects are: Headache; dizziness, vertigo, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia, transaminases increased, rash.
Rare undesirable effects are: Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock), somnolence, asthma (including dyspnea), gastritis, gastrointestinal hemorrhage, hematemesis, diarrhea hemorrhagic, melaena, gastrointestinal ulcer (with or without perforation), hepatitis jaundice, liver disorder, urticaria, edema.
Very rare undesirable effects are: Thrombocytopenia, leukopenia, anemia (including hemolytic anemia and aplastic anemia), agranulocytosis, angioneurotic edema (including face edema), disorientation, depression, insomnia, nightmare, irritability, psychotic disorder, paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident, visual disturbance, vision blurred, diplopia, tinnitus, hearing impaired, palpitations, chest pain, cardiac failure, myocardial infarction, hypertension, vasculitis, pneumonitis, colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn’s disease), constipation, stomatitis, glossitis, esophageal disorder, diaphragm-like intestinal strictures, pancreatitis, fulminant hepatitis, hepatic necrosis/hepatic failure, bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus, acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
Cataflam® Basic Succinct Statement version dated 26 May 2010
EURAX® 10% LOTION
One gram of cream or lotion contains 100mg of crotamiton.
Topical treatment of scabies, pruritus and pediculosis capitis.
Acaricide agent: An application to the entire body surface preferably in the evening. Repeat the application for 3 to 5 days, depending on the results. The bed-linen and underclothing have to be changed. After completion of the treatment, a cleansing bath should be taken.
Antipruritic agent: An application to the site of the itching followed by gentle massage twice or three times a day.
Pediculicide agent: A single application on the scalp and on the hair for 24 hours. Then wash and comb the hair so as to remove the nits. On the 8th day, carefully examine the hair and scalp. If necessary repeat the treatment.
The bed-linen and underclothing have to be changed.
Hypersensitivity to the active substance or to any of the excipients.
For external use only. Should not be used in buccal mucosa and in or around the eyes since contact with the eyelids may give rise to conjunctival inflammation. In case of accidental contact with the eyes, or buccal mucosa rinse thoroughly with running water. Should not be applied in the presence of exudative wounds, acute eczema, broken skin, or very inflamed skin. In the presence of eczematous scabies, eczema should be treated before the scabies.
This medicinal product contains propylene glycol which may cause skin irritation, and the excipients sorbic acid, cetostearyl alcohol and wool fat which may cause local skin reactions (e.g. contact dermatitis).
No interaction studies have been performed.
Rare: contact dermatitis, hypersensitivity (including/like rash, eczema, erythema, skin irritation, angioedema)
Treatment should be discontinued if severe irritation occurs.
Eurax® Core Summary of Product Characteristics version dated 28 May 2009
Procto-Glyvenol (tribenoside + lidocaine HCl)
One gram of Procto-Glyvenol rectal cream contains 50 mg of tribenoside and 21.2 mg of lidocaine hydrochloride.
Local treatment of external and internal hemorrhoids.
Apply the rectal cream in the morning and evening until acute symptoms have diminished, after which the dosage can be reduced to once a day.
Hypersensitivity to the active substances or to any of the excipients.
Procto-Glyvenol should be used with precaution in patients suffering from severe hepatic damage.
Procto-Glyvenol cream contains:
- cetyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
- methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Procto-Glyvenol may be used as from the 4th month of pregnancy and during breast-feeding, however the recommended dosing should not be exceeded.
No interaction studies have been performed.
Very rare: Anaphylactic reaction, cardiovascular disorder, angioedema, bronchospasm, face edema.
Rare: Urticaria, Application site pruritus, application site rash, application site pain.
Procto-Glyvenol® Core Summary of Product Characteristics version dated 26 May 2011
TAVEGYL® 1 mg TABLET
Each Tavegyl tablet contains 1.34 mg of clemastine fumarate equivalent to 1 mg clemastine.
Tavegyl is indicated for the relief of hay fever and other allergic rhinitis, urticaria of various origin, including dermatographic urticaria, pruritus, itching dermatoses and insect stings and bites. Tavegyl is also indicated as an adjuvant in acute and chronic eczema, contact dermatitis and drug eruptions.
The tablets should be taken with water before meals.
For adults and children over 12 years old: 1 tablet, morning and evening.
In refractory cases, up to 6 tablets daily may be given.
Hypersensitivity to clemastine or other similar antihistamines or to any of the excipients.
Tavegyl should not be given to patients suffering from porphyria.
Antihistamines should be used with caution in patients with:
- narrow-angle glaucoma
- stenosing peptic ulcer
- pyloroduodenal obstruction
- prostatic hypertrophy with urinary retention and bladder neck obstruction
Tavegyl tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Tavegyl should not be taken during pregnancy nor breast-feeding.
Antihistamines potentiate the sedative effects of hypnotics, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, anxiolytics, opioid analgesics and alcohol.
Common: Fatigue, sedation
Rare: Headache; excitability; gastralgia, nausea, dry mouth; skin rash; dyspnea; hypersensitivity reactions
Very rare: Constipation; tachycardia
Tavegyl® Core Data Sheet version dated 08 April 2010