Hidrasek 100 mg x 10 capsules Laboratoires Sophartex

HIDRASEC / HIDRASEC x 10 capsules.
Description: Hidrasec contains an active substance called racecadotril. It acts on the intestinal wall and suppresses the increased secretion of fluids and salts caused by inflammation. Racecadotril exerts a rapid antidiarrheal effect without changing the duration of passage through the digestive tract. It is used as a symptomatic treatment of acute diarrhea in adults. Administration and dosage: Always use Hidrasec exactly as your doctor has told you. If you are not sure about something, ask your doctor or pharmacist. Hidrasec is administered by mouth with concomitant administration of fluids. The initial dose is one capsule, regardless of the time of day. Then - one capsule three times a day, preferably - before a main meal. Treatment should not last more than 7 days. Children There are separate formulations intended for infants, children and adolescents. Elderly patients No dose adjustment is necessary for elderly patients. If you take more Hidrasec than you should If you take more Hidrasec than you should, contact your doctor or go to a hospital immediately, taking the medicine package with you. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the missed dose. Take the medicine for as long as your doctor has prescribed. Do not stop taking it just because you feel better. If you have any further questions on the use of this medicine, please ask your doctor or pharmacist. HIDRASEC / HIDRASEC capsule composition: Each capsule contains the active substance racecadotril 100 mg. The other ingredients are: lactose, corn starch, magnesium stearate, colloidal silicon dioxide, yellow iron oxide (El72), titanium dioxide (El71), gelatin. Hidrasec 100 mg hard capsules Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you personally. Do not pass it on to other people. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Hidrasec is and what it is used for 2. Before you take it 3. How to use Hidrasec 4. Possible side effects 5. How to store Hidrasec 6. Further information 1. WHAT HIDRASEQ IS AND WHAT IT IS USED FOR Hidrasec contains an active substance called racecadotril. It acts on the intestinal wall and suppresses the increased secretion of fluids and salts caused by inflammation. Racecadotril exerts a rapid antidiarrheal effect without changing the duration of passage through the digestive tract. It is used as a symptomatic treatment of acute diarrhea in adults. 2. BEFORE YOU TAKE HYDRASEC You should not use this medicine if: – you have a known hypersensitivity to the active substance or to any of the excipients. If you are not sure if any of the above apply to you, please ask your doctor! Take special care with Hidrasec The use of the medicine does not change the usual fluid replacement regimen. The presence of blood or pus in the stool may indicate the presence of bacteria as the cause of the diarrhoea or another serious illness. Therefore, racecadotril should not be used in such cases. There are no sufficient studies on the effect of this medicine on chronic diarrhoea. Furthermore, racecadotril has not been studied in diarrhoea associated with antibiotics. There are no sufficient data in patients with renal or hepatic impairment. Such patients should be treated with caution. The medicine should not be used in patients with prolonged or uncontrolled vomiting. Taking other medicines Please inform your doctor if you are taking any medicines! No interactions with other medicines have been established. Pregnancy and breast-feeding Please inform your doctor if you are pregnant or breast-feeding or intend to become pregnant! Pregnancy There are no sufficient data from the use of racecadotril in pregnant women. The product should not be used during pregnancy. Breast-feeding Due to the lack of information related to the secretion of the medicinal product in breast milk, it should not be used in breast-feeding women. Driving and using machines The influence of racecadotril on the ability to drive and use machines is non-existent or negligible. 3. HOW TO USE HYDRASEC Always take HYDRASEC exactly as your doctor has told you. If you are not sure about anything, ask your doctor or pharmacist. HYDRASEC is administered by mouth with concomitant administration of fluids. The initial dose is one capsule, regardless of the time of day. Then - one capsule three times a day, preferably - before a main meal. Treatment should not last longer than 7 days. Children There are separate formulations intended for infants, children and adolescents. Elderly patients No dose adjustment is necessary for elderly patients. If you take more Hidrasec than you should If you take more Hidrasec than you should, contact your doctor or go to a hospital immediately, taking the medicine package with you. If you forget to take Hidrasec If you forget to take your dose, take it as soon as you remember. However, if it is almost time for your next dose, skip it. Do not take a double dose to make up for the missed one. Take the medicine for as long as your doctor has prescribed. Do not stop taking it just because you feel better. If you have any further questions on the use of this medicine, please ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects listed below have occurred more frequently with racecadotril than with placebo or have been reported during post-marketing surveillance. The frequency of adverse reactions is categorized based on the following classification: very common (> 1/10), common (> 1/100 to 1/1,000 to 1/10,000 to Nervous system disorders Common – headache. Skin and subcutaneous tissue disorders Uncommon – rash, redness (erythema). Unknown – a special type of redness (erythema multiforme), swelling of the tongue, swelling of the face, lips, eyelids, swelling of vascular origin, urticaria, erythema nodosum, rash, skin changes with itching, persistent itching. 5. HOW TO STORE HYDRASEC No special storage conditions. Shelf life – 2 (two) years. Hidrasec should not be used after the expiry date stated on the packaging. The expiry date corresponds to the last day of the month indicated. Medicines should not be thrown away in the sewage system or in the container household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. FURTHER INFORMATION What Hidrasec contains Each capsule contains the active substance racecadotril 100 mg. The other ingredients are: lactose, maize starch, magnesium stearate, colloidal silicon dioxide, yellow iron oxide (El72), titanium dioxide (El71), gelatin What Hidrasec looks like and contents of the pack Hidrasec 100 mg hard capsules are ivory, 10 capsules in a PVC-PVDC/Aluminium foil blister, 1 or 2 blisters in a box Marketing Authorisation Holder Laboratories Fournier SA 28 Boulevard Clemenceau, 21000 Dijon, France Manufacturer Laboratoires Sophartex 21 Rue de Pressoir 28500 Vernoillet France For any information about this medicine, please contact the local representative of the holder of the marketing authorization: Bulgaria Abbott Products EOOD. Blvd. Al. Stamboliyski 103 fl.5 Sofia 1303 Tel. +359 44 55 400