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.
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 orthopaedic surgery.
Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis.
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.
Caution recommended in patients with symptoms/history of gastrointestinal (GI) disease and in elderly because of the risks of GI bleeding or perforation. To be discontinued if these conditions occur.
Combined use with protective agents to be considered in patients with history of ulcer, elderly and those requiring low dose aspirin.
Caution when used concomitantly with corticosteroids, anticoagulants, anti-platelets agents or SSRIs.
Caution recommended in patients with ulcerative colitis or Crohn`s disease.
Caution recommended is patients with asthma, seasonal allergic rhinitis or chronic pulmonary diseases.
Risks of serious allergic reactions. To be discontinued if these conditions occur.
Caution recommended in patients with impaired hepatic function (including porphyria).
Monitoring of liver function during prolonged treatment.
Beware of severe fluid retention and edema.
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 of blood counts recommended during prolonged treatment.
Monitoring recommended in patients with defect of haemostasis.
Monitoring recommended for elderly.
Avoid use with other systemic NSAIDs including COX-2 inhibitors.
Caution in patients with CV risk factors.
May mask signs and symptoms of infection.
Pregnancy and breast-feeding: Should not be used in the first and second trimester of pregnancy and by breast-feeding mothers.
Fertility: Not recommended to use in women attempting to conceive as it may impair female fertility.
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. Monitoring of serum potassium level if used concomitantly with drugs known to cause hyperkalemia (e.g. diuretics, cliclosporin, tacrolimus, trimethoprim).
Common undesirable effectsare: Headache; dizziness, vertigo, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, decreased appetite, transaminases increased, rash.
Rare undesirable effectsare: Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock), somnolence, asthma (including dyspnea), gastritis, gastrointestinal hemorrhage, hematemesis, diarrhea hemorrhagic, melena, gastrointestinal ulcer (with or without bleeding or perforation), hepatitis jaundice, liver disorder, urticaria, edema.
Very rare undesirable effectsare: Thrombocytopenia, leukopenia, anemia (including hemolytic anemia and aplastic anemia), agranulocytosis, angioedema (including face edema), disorientation, depression, insomnia, nightmare, irritability, psychotic disorder, paresthesia, memory impairment, convulsion, anxiety, tremor, meningitis aseptic, dysgeusia, cerebrovascular accident, visual impairment, 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, intestinal diaphragm disease, pancreatitis, hepatitis fulminant, hepatic necrosis/hepatic failure, dermatitis bullous, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, alopecia, photosensitivity reaction, purpura, Henoch-Schonlein purpura, pruritus, renal failure acute, hematuria, proteinuria, nephrotic syndrome, tubulointerstitial nephritis, renal papillary necrosis.
Cataflam® Basic Succinct Statement version dated 10 Feb 2012
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
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
Orofar-L (benzoxonium Cl + lidocaine HCl)
Infections in the mouth & throat
OROFAR-L GARGLE SOLUTION
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.
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.
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. 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
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
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
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. Localized forms of soft-tissue rheumatism, e.g. tendovaginitis, bursitis, shoulder-hand syndrome, and periarthropathy. Localized forms of degenerative rheumatism, e.g. osteoarthrosis of the peripheral joints and vertebral column.
Adults: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.
Special patient populations: No dosage adjustment of the starting dose is required.
Known hypersensitivity to diclofenac or to any of the excipients.
Known hypersensitivity to Aspirin or to other non-steroidal anti-inflammatory drugs (NSAIDs).
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.
Pregnancy and breast-feeding:Contraindicated in the third trimester of pregnancy.Avoid use during pregnancy. Not recommended during breast-feeding.
Excipients:Voltaren Emulgel contains propylene glycol, which may cause mild, localized skin irritation in some people.
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, and angioedema.
Voltaren® Emulgel® Basic Succinct Statement version dated 10 Feb 2012
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