FORTEX DIARID PRO 2mg fast and effective action in diarrhea x 10 tabl
DIARID PRO 2 mg tablets
loperamide hydrochloride
DIARID PRO 2 mg tablets
loperamide hydrochloride
FAST AND EFFECTIVE ACTION FOR DIARRHEA
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 2 days you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains
1. What DIARID PRO is and what it is used for
2. What you need to know before you take DIARID PRO
3. How to take DIARID PRO
4. Possible side effects
5. How to store DIARID PRO
6. Contents of the package and additional information
1. What DIARID PRO is and what it is used for
DIARID PRO contains loperamide hydrochloride, which belongs to the group of drugs against diarrhea (anti-propulsive) - normalizes bowel movement, hardens stools and increases the ability to retain stools.
DIARID PRO is used for sudden onset (acute) diarrhea or for prolonged (chronic) diarrhea. It is also used in case of diarrhea after some gastrointestinal operations or inability to retain stools (faecal incontinence).
If after two days you do not feel better or your condition worsens, you should seek medical attention.
2. What you need to know before you take DIARID PRO
Do not take DIARID PRO:
- if you are allergic to loperamide hydrochloride or to any of the other ingredients of this medicine (listed in point 6);
- if there is blood in the stool or if you have a high temperature (intestinal infection caused by bacteria such as salmonella, shigella and campylobacter);
- in inflammation of the large intestine (for example, ulcerative colitis or pseudomembranous colitis caused by antibiotic treatment);
- if you suffer from conditions in which a delay in bowel functions should be avoided, for example a swollen abdomen, constipation or intestinal obstruction (ileus).
Warnings and precautions
Treatment with DIARID PRO relieves the symptoms, but does not treat the cause of the diarrhea.
Therefore, before long-term treatment, it is necessary to examine yourself and start effective treatment.
Talk to your doctor or pharmacist before taking DIARID PRO if:
- diarrhea still persists after treatment for two days;
- constipation or other signs of bowel obstruction appear;
- you have impaired liver function;
- you have AIDS, stop treatment with DIARID PRO at the first sign of abdominal swelling.
In a state of diarrhea, you lose a significant amount of fluids. Therefore, it is important to have an increased fluid intake in this condition. This is especially true for children.
Take this medicinal product only and only as intended (see point 1 "What is DIARID PRO and what it is used for") and never take more than the recommended dose (see point 3 "How to take DIARID PRO").
There have been reports of serious heart problems - a fast or irregular heartbeat - in patients taking too much loperamide hydrochloride.
Children and adolescents
DIARID PRO is not recommended for children under 6 years of age.
Other medicines and DIARID PRO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can affect or be affected by treatment with DIARID PRO if they are taken at the same time. Examples of such drugs are:
- cholestyramine and gemfibrozil (cholesterol-lowering medicines);
- quinidine (used to treat heart rhythm disorders and malaria);
- ritonavir (used to treat HIV/AIDS);
- cyclosporine (immune system inhibitor);
- verapamil (lowers blood pressure);
- erythromycin and clarithromycin (antibiotics);
- itraconazole and ketoconazole (medicines to treat fungal infections);
- oral desmopressin (medicine to control the amount of urine produced).
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Taking DIARID PRO during pregnancy is not recommended.
Breastfeeding
Taking DIARID PRO is not recommended if you are breast-feeding, as small amounts of loperamide hydrochloride may pass into breast milk.
Driving and using machines
This medicine has no influence on driving and operating machines. Along with diarrhea, fatigue, dizziness or drowsiness may occur. Therefore, it is recommended to be careful when driving or operating machinery.
DIARID PRO contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
DIARID PRO contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it can be said to be practically sodium-free.
3. How to take DIARID PRO
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults and children over 6 years:
Acute diarrhea: the starting dose is 2 tablets (4 mg) in adults and 1 tablet (2 mg) in children over 6 years of age. Treatment continues with 1 tablet (2 mg) after each loose stool.
Chronic diarrhea: the starting dose is 2 tablets (4 mg) daily for adults and 1 tablet (2 mg) for children over 6 years of age. This starting dose can be adjusted to achieve 1-2 formed stools per day, which is usually achieved with a maintenance dose of 1-6 tablets (2-12 mg) daily.
The maximum dose for adults is 8 tablets (16 mg) daily. Do not take more than 8 tablets per day.
For children over 6 years of age, the dose should be based on body weight (3 tablets/20 kg), but should not exceed the dose of 8 tablets per day.
The tablets should be swallowed whole with half a glass of water.
If you have taken more than the required dose of DIARID PRO
If you have overdosed on DIARID PRO, please contact your doctor immediately.
Overdose symptoms may include:
- increased heart rate;
- irregular pulse, changes in heart activity (these symptoms can have serious life-threatening consequences);
- muscle stiffness;
- difficulty breathing;
- uncoordinated movements;
- drowsiness;
- difficulty urinating.
In children, the reaction to an overdose with loperamide hydrochloride is more pronounced. Contact a doctor immediately if the child has experienced any of the above symptoms.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure about something, ask your doctor.
If you have forgotten to take DIARID PRO
Do not take a double dose to make up for a missed dose.
If you have stopped taking DIARID PRO
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking DIARID PRO immediately and contact your doctor if you experience any of the following side effects:
- sudden swelling of the face, lips, tongue or throat, difficulty swallowing or hives and difficulty breathing - these are signs of angioedema;
- extreme tiredness, problems with coordination and loss of consciousness;
- severe abdominal pain and/or bloating, which may be a sign of a blocked or enlarged bowel;
- Stevens-Johnson syndrome: an allergic reaction with a rash, usually in the form of blisters or sores on the eyes, skin and/or mucous membranes;
- Lyell's syndrome: toxic epidermal necrolysis.
Common (≥1/100, <1/10): constipation, nausea, flatulence, headache and dizziness.
Uncommon (≥1/1000, <1/100): drowsiness, pain or stomach discomfort, dry mouth, vomiting, indigestion and rash.
Very rare (<1/10,000): hypersensitivity reactions such as anaphylactic shock, muscle stiffness, incoordination, drowsiness, fatigue, stupor, miosis (narrowing of the pupil of the eye), ileus (intestinal obstruction), megacolon (dilation of the colon bowel), angioedema (edema), bullous rash, pruritus, urticaria, urinary retention.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly via
The Medicines Executive Agency,
8 Damyan Gruev St., 1303 Sofia, Bulgaria,
phone: +359 2 8903417,
website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store DIARID PRO
No special storage conditions.
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton/blister after EXP. The expiration date corresponds to the last day of the specified month.
Do not use this medicine if you notice a violation of the quality of the product.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What DIARID PRO contains
- The active substance is loperamide hydrochloride. Each tablet contains 2 mg of loperamide hydrochloride.
- Excipients: lactose monohydrate, corn starch, partially pregelatinized corn starch, croscarmellose sodium, silicon dioxide (colloidal, anhydrous), magnesium stearate, povidone K25.
What DIARID PRO looks like and what the package contains
DIARID PRO is supplied in a cardboard box containing 1 or 2 white, opaque PVC/PVDC/Alu foil blisters of 10 tablets each, together with a patient leaflet.
Not all types of packaging can be marketed.
Marketing Authorization Holder and Manufacturer
Fortex Nutraceuticals Ltd
10 Prohladen kat St.,
Sofia 1362, Bulgaria
Date of last revision of leaflet
March 2021
