Package Leaflet: Information for the patient
DIARID PRO 2mg tablets
Read the whole leaflet carefully before you start using this medicine, because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.
- Keep this leaflet. You may need to read it again.
- If you need any additional information or advice, please speak to your pharmacist.
- If you experience any unwanted effects, please contact your doctor or pharmacist. This includes all unwanted effects that may not be listed in this leaflet. Please see section 4.
- If after 2 days you do not feel better or your condition worsens, please seek medical assistance.
What is in this leaflet?
1. What is DIARID PRO and what is it 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 on the pack and additional information
1. What is DIARID PRO and what is it used for
DIARID PRO contains the active substance loperamide hydrochloride, which belongs to the group of medicines used to treat diarrhea (antipropulsives) – it normalizes movement in the bowel, hardens feces and increases your ability to withhold them.
DIARID PRO is used for sudden (acute) diarrhea or for prolonged (chronic) diarrhea. It is used for diarrhea after a gastrointestinal surgery or inability to contain your feces (fecal incontinence).
If after two days you do not feel better or your condition worsens, you need to seek medical assistance.
2. What you need to know before taking DIARID PRO
Do not take DIARID PRO:
- If you are allergic to loperamide hydrochloride or any of the other ingredients (listed in section 6);
- If you have blood in your feces or if you have a fewer (intestinal infection, caused by bacteria such as salmonella, shigella and campylobacter);
- If you have a colon infection (such as ulcerative colitis or pseudomembranous colitis, caused by antibiotic treatment);
- If you suffer from a condition where you should avoid slowing down an overactive bowel, such as bloating, constipation or gastrointestinal blockage (ileus).
Warnings and precautions
Treatment with DIARID PRO relieves the symptoms but does not treat the cause of the diarrhea.
Before long-term treatment you need to get examined and start an effective treatment.
Speak to your doctor or pharmacist before taking DIARID PRO if:
- You still have diarrhea after two days of active treatment;
- You have constipation or any other symptoms of a blocked gastrointestinal tract;
- You have impaired liver function
- You have AIDS stop using DIARID PRO with the first symptoms of a bloated abdomen
When you have diarrhea, you lose a significant amount of liquids. That is why it is important to increase your liquid intake when you have diarrhea. This is of upmost importance in children.
Use this product what it is intended for only (See section 1 “What is DIARID PRO and what is it used for”) and never take more than the recommended dosage (See section 3 “How to use DIARID PRO”)
Patients who take too much loperamide hydrochloride report serious heart problems – irregular or sped up pulse.
Children and adolescents
DIARID PRO is not recommended for children under 6 years old.
Other medicines and DIARID PRO
Tell your doctor or pharmacist if you are currently taking, have recently taken or know there is a possibility for you to start taking other medicines.
Some medicines might affect or be affected by treatment with DIARID PRO, if taken at the same time. Such medicines are:
- Cholestyramine and gemfibrozil (medicines that lower cholesterol levels);
- Quinidine (used to treat impaired heart beat and malaria);
- Ritonavir (used to treat AIDS/HIV);
- Cyclosporin (immune system inhibitor);
- Verapamil (decreases blood pressure);
- Erythromycin and clarithromycin (antibiotics);
- Itraconazole and ketoconazole (used to treat yeast infections);
- Oral desmopressin (used to control amount of urine)
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you might be pregnant or are planning a pregnancy consult with your doctor or pharmacist before using this medicine.
Using DIARID PRO during pregnancy is not recommended.
Taking DIARID PRO when breastfeeding is not recommended, because small amounts of loperamide hydrochloride can get into the breast milk.
Driving and working with machines
This medicine does not affect driving or working with machines. Diarrhea may cause tiredness, dizziness and sleepiness. This is why it is recommended to be careful while working or working with machines.
DIARID PRO contains lactose
If your doctor has told you that you have intolerance towards certain kinds of sugars, contact them before taking this medicine.
DIARID PRO contains sodium
This medicine contains less than 1mmol sodium (23mg) per tabled, meaning it practically does not contain it.
3. How to take DIARID PRO
Always take this medicine as your doctor or pharmacist has told you to. If you are unsure about something, ask your doctor or pharmacist.
The recommended dosage is:
Adults and children over 6 years old:
Acute diarrhea: initial dosage is 2 tablets (4mg) for adults and 1 tablet (2mg) for children over 6 years old. The treatment continues with taking 1 tablet (2mg) every time after having watered down feces.
Chronic diarrhea: initial dosage is 2 tablets (4mg) per day for adults and 1 tablet (2mg) for children over 6 years old. The dosage can be increased with the goal of having a few formed stools a day, usually achieved through a dose that is maintained within 1-6 tablets (2-12mg) per day.
Maximal dosage for adults is 8 tablets (16mg) per day. Do not take more than 8 tablets in one day.
The dosage for children over 6 years old is determined by their weight (3 tablets/20kg), but should not be over 8 tablets a day.
The tablets must be taken whole with half a glass of water.
If you have taken more than the recommended dosage of DIARID PRO
If you have overdosed with DIARID PRO, please immediately contact your doctor. Symptoms of overdose may include:
- Increased heart rhythm
- Irregular pulse, changes in heart beat (these symptoms may have serious life-threatening consequences)
- Muscle rigidity
- Difficulty breathing
- Uncoordinated movements
- Difficulty urinating
Children have a more serious reaction to loperamide hydrochloride. Immediately contact a doctor if the child is experiencing any of the symptoms stated above.
Always take this medicine as described in this leaflet or as you doctor or pharmacist has told you to. If you are unsure about something, ask your doctor.
If you missed taking DIARID PRO
Do not take a double dose to compensate the one you missed.
If you have stopped taking DIARID PRO
If you have any additional questions regarding using this medicine, ask your doctor or pharmacist.
4. Possible unwanted effects
Like all medicines, this medicine may cause unwanted effects, even though not everyone experiences them.
Immediately stop taking DIARID PRO and contact your doctor if you experience any of the following unwanted effects:
- Sudden swelling of the face, lips, tongue or throat, difficulty swallowing or hives or difficulty breathing – those are symptoms of angioedema;
- Tiredness, problems with coordination and unconsciousness;
- Strong abdominal pain and/or bloating, which could be a sign of a blocked or expanded colon;
- Stevens-Johnson syndrome: allergic reaction with a rash, usually like a blister or ulcers underneath or on the eyes, skin and/or the mucus membranes;
- Lyle syndrome: toxic epidermal necrolysis.
Common (>1/100, <1/10): constipation, sickness, gases, headache or dizziness.
Rare (>1/1000, <1/100): sleepiness, abdominal pain or discomfort, dry mouth, vomiting, impaired digestion and a rash.
Very rare (<1/10 000): super sensitivity such as anaphylactic shock, sore muscles, impaired coordination, sleepiness, tiredness, stupor, myosis (shrinkage of the pupil in the eye), ileus (intestinal obstruction), megacolon (enlarged colon), angioedema, bullous rash, itchiness, hives, withholding urine.
Reporting of side effects
If you experience any unwanted effects, let your doctor or pharmacist know. This includes all effects not listed in this leaflet. You can also report your unwanted side effects here:
Executive Pharmacies Agency
8 Damian Gruev str, 1303 Sofia, Bulgaria
+359 2 8903417,
By reporting side unwanted effects, you can contribute to receiving more information about the safety of this medicine.
5. How to store DIARID PRO
No special conditions are required to store.
Needs to be stored in a space unreachable to children.
Do not use this medicine past the expiry date, marked on the cardboard box, after “Use before:”. The expiry date refers to the last day of that month.
Do not use this product if you notice any damage to its quality.
Do not throw the medicine in the canalization or in the container used for household waste. Ask your pharmacist how to get rid of medicines you are no longer using. These precautions will help with keeping the environment clean.
6. Contents of the pack and additional information
Contents of DIARID PRO
- The active ingredient is loperamide hydrochloride. Every tablet contains 2 mg loperamide hydrochloride.
- Additional ingredients: lactose monohydrate, cornstarch, croscarmellose sodium, silicon dioxide, magnesium stearate, povidone K25.
What DIARID PRO looks like and what the pack contains
DIARID PRO is stored in a cardboard box, containing 1 or 2 blisters of a while, non-transparent PVC/PVDC/Alu foil with 10 tablets each, along with the patient leaflet.
Not all packs can be put on the market.
Marketing Authorization Holder and Manufacturer
Fortex Nutraceuticals Ltd.
10 Prohladen kat str
Sofia 1362, Bulgaria
This leaflet was last revised in April 2022