Relafalk 200 mg. 12 tablets

What Relafalk is and what it is used for
Relafalk contains the active substance rifamycin sodium, an antibiotic that works in the colon. It is used to treat traveller's diarrhea accompanied by symptoms such as nausea, vomiting, gas, frequent urge to defecate, abdominal pain or cramping in adults. Relafalk should not be used when diarrhea is accompanied by fever or blood in the stool.

2. What you need to know before you take Relafalk
Do not take Relafalk:
if you are allergic to rifamycin sodium, similar types of antibiotics, or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from vomiting, abdominal pain or constipation caused by a bowel obstruction;
if you have a perforation, wound or injury in the digestive system;
if you have diarrhea with fever or blood in your stools.
Relafalk contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicinal product.

Warnings and precautions
Talk to your doctor or pharmacist while you are taking Relafalk:

if your symptoms get worse during treatment;
if you do not feel better after 3 days of treatment;
if your symptoms come back soon after stopping treatment.
While taking this medication, a reddish color to the urine may occur.

Contact your doctor if you have symptoms such as frequent watery diarrhea, severe cramping or abdominal pain, fever, or blood in your stool. This may be due to an infection (Clostridium difficile-related diarrhea) that requires emergency medical attention.

If you are being treated with an antibiotic of the rifamycin class for a disease caused by mycobacteria (eg tuberculosis), you should not take Relafalk.

Children and adolescents
There is no experience of using Relafalk in children and adolescents.
For this reason, do not give this medicine to children and adolescents under 18 years of age.

Other medicines and Relafalk
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Relafalk should not be taken together with a similar type of antibiotic.
Tell your doctor if you are taking cyclosporine (an immunosuppressant), warfarin (a blood thinner), or oral contraceptives.
If you are taking activated charcoal (for example to treat diarrhoea), take Relafalk at least 2 hours after taking the charcoal.
Pregnancy and breastfeeding
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. Do not take Relafalk if you are pregnant or breast-feeding, unless your doctor has told you to.

Driving and using machines
Relafalk is unlikely to affect your reactions when you drive and operate machinery. Do not drive or use machines if you feel dizzy or tired after taking Relafalk.

Relafalk 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 Relafalk
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended daily dose for adults over 18 years of age is:
Two tablets in the morning and two tablets in the evening for three days.
Unless otherwise prescribed, the duration of treatment should not exceed three days. If you don't feel better after three days, talk to your doctor.
Use in children and adolescents
Relafalk is not intended for use in children and adolescents under 18 years of age.

How to take the tablets:
Take the tablets with a glass of water. The tablets should be swallowed whole. Do not crush or chew.
The tablets can be taken with or without food.
If you have taken more than the required dose of Relafalk
Contact a doctor if you accidentally take more than the recommended dose.

If you forget to take Relafalk
Do not take a double dose to make up for a missed dose. Take your next dose as prescribed.

If you have stopped taking Relafalk
The recommended duration of treatment is three days. Talk to your doctor if your symptoms get worse during treatment or if you don't feel better after 3 days.

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.

Common: may affect up to 1 in 10 people:

Headache;
Diarrhea.
Uncommon: may affect up to 1 in 100 people:

Loss of appetite;
Anxiety;
Dizziness;
Abdominal cramps and spasms, bloating, upper abdominal pain, abdominal pain, aphthous ulceration (in the mouth), constipation, frequent urge to defecate, dry mouth, dyspepsia, belching, flatulence, increased stomach acid in
5. How to store Relafalk
Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiration date corresponds to the last day of the specified month.

Do not store above 30°C.

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 Relafalk contains
The active substance is: rifamycin sodium. Each modified-release tablet contains 200 mg of rifamycin sodium.
The other excipients are: ammonium methacrylate copolymer (type B), ascorbic acid (E300), glycerol distearate, soy lecithin (E322), magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), macrogol 6000 (E1521), colloidal anhydrous silica (E551), talc, titanium dioxide (E171), triethyl citrate (E1505), iron oxide, yellow (E172).
What Relafalk looks like and contents of the pack
Relafalk 200 mg modified-release tablets are yellow-brown, elliptical tablets marked with “SV2” on one side.

They are available in blister packs containing 12 tablets.

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