Patient leaflet - Travyc 200 mg modified-release tablets
1. What Travyc is and what it is used for
Travyc (pronounced Træ-vɪk). contains the active substance rifamycin sodium, an antibiotic that acts in the bowel. It is used to treat traveller’s diarrhoea accompanied by symptoms like nausea, vomiting, flatulence, frequent urge to empty the bowels, abdominal pain or cramps in adults. Travyc is not to be used when the diarrhoea is accompanied by fever or blood in the stools.
2. What you need to know before you take Travyc
Do not take Travyc if you:
- are allergic to rifamycin sodium, similar types of antibiotics or any of the other ingredients of this medicine (listed in section 6)
- suffer from vomiting, abdominal pain or constipation caused by blockage of the bowels
- have a perforation, wound or injury in the digestive system
- have diarrhoea with fever or blood in the stools
Travyc contains soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.
Warnings and precautions
Talk to your doctor or pharmacist while taking Travyc if:
- your symptoms worsen during treatment
- you do not feel better after 3 days’ treatment
- your symptoms reoccur shortly after stopping treatment
A reddish discolouration of the urine can occur while taking this medicine.
Contact your doctor if you experience symptoms such as frequent watery diarrhoea, severe abdominal cramps or pain, fever or blood in your stool. This may be due to an infection (Clostridium difficile associated diarrhoea), which requires immediate medical attention.
If you are being treated with a rifamycin class antibiotic for mycobacterial disease (e.g. tuberculosis), you should not take Travyc.
Children and adolescents
There is no experience with the use of Travyc in children and adolescents.
Therefore, do not give this medicine to children and adolescents below 18 years of age.
Other medicines and Travyc
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Travyc should not be taken together with similar types of antibiotics.
- Tell your doctor if you are taking ciclosporine (immunosuppressant), warfarin (medicine to thin the blood) or oral contraceptives.
- If you take activated charcoal (for example to treat diarrhoea), take Travyc at least 2 hours after taking charcoal.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Travyc if you are pregnant or breast-feeding, unless your doctor tells you to.
Driving and using machines
Travyc is unlikely to affect your reactions when driving and using machines. Do not drive or use machines if you experience dizziness or tiredness after taking Travyc.
Travyc contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
3. How to take Travyc
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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. Talk to your doctor if you do not feel better after three days.
Use in children and adolescents
Travyc is not intended for use in children and adolescents below 18 years of age.
How to take the tablets:
- Take the tablets with a glass of water. Swallow whole. Do not crush or chew.
The tablets can be taken with or without food.
If you take more Travyc than you should
Contact a doctor if you have accidentally taken more than the recommended dose.
If you forget to take Travyc
Do not take a double dose to make up for a forgotten dose. Take your next dose as prescribed.
If you stop taking Travyc
The recommended duration of treatment is three days. Talk to your doctor if your symptoms worsen during treatment or if you do not feel better after 3 days.
If you have any further questions on 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
- Diarrhoea
Uncommon: may affect up to 1 in 100 people
- Loss of appetite
- Anxiety
- Dizziness
- Abdominal cramps and spasms, abdominal distension, upper abdominal pain, abdominal tenderness, aphthous (mouth) ulcer, constipation, frequent urge to empty the bowels, dry mouth, dyspepsia, belching, flatulence, increase of gastric acid in the stomach, nausea
- Hair loss, increased sweating, night sweats, itching
- Muscle and joint pain, back pain, pain in the extremities and sides, muscle spasm and muscle weakness
- Abnormal urine colour, painful or difficult urination, diminished amount of urine
- Weakness, chest pain, general feeling of being ill, pain, fever
- Changes in liver function parameters (ALT increased), changes to the blood (increased creatinine and urea)
The following side effects have been reported with antibiotics similar to Travyc, and can therefore also occur with this medicine. The frequency of these side effects is currently not known:
- Bacterial infections (Clostridial infections), fungal infections
- Abnormal blood test results (reduced platelets)
- Severe acute reactions to the drug (anaphylactic reactions), allergic reactions to the drug
- Serious allergic reaction which causes swelling of the face or throat, itchy rash, skin redness/roughness
- Swelling of ankles and/or lower legs due to accumulation of fluid
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Travyc
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Travyc contains
- The active substance is rifamycin sodium. Each modified-release tablet contains 200 mg of rifamycin sodium.
- The other excipients are: ammonio methacrylate copolymer (Type B), ascorbic acid (E300), glycerol distearate, soya lecithin (E322), magnesium stearate, mannitol, methacrylic acid-methyl methacrylate copolymer (1:2), macrogol 6000 (E1521), silica colloidal anhydrous (E551), talc, titanium dioxide (E171), triethyl citrate (E1505), iron oxide yellow (E172).
What Travyc looks like and contents of the pack
Travyc 200 mg modified-release tablets are yellow-brown ellipsoidal tablets marked with “SV2” on one side.
They are available in blister packs containing 12 tablets.
Marketing Authorisation Holder
Adalvo Competence Center S.R.L.
47 Theodor Pallady Blvd
Building HBC, entrance B
032258 Bucharest
Romania
Manufacturer
Cosmo S.p.A
Via C. Colombo, 1
20045, Lainate
Milan, Italy
Phone: +39 02 93 3371
Fax: +39 02 93 33 7663
Email: glo-regulatory@cosmopharma.com
This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgaria, Denmark, Finland, Hungary, Norway, Poland, United Kingdom: Travyc
Greece, Portugal, Spain, Sweden: Rifamycin Adalvo
Germany: Gutivia