Pylera - Consumer Medicine Information
|Manufacture:||Forest Laboratories, Inc.|
|Condition:||Helicobacter Pylori Infection|
|Class:||H. pylori eradication agents|
|Ingredients:||bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride, magnesium stearate (E572), lactose monohydrate, talc (E553b), titanium dioxide (E171), gelatin and printing ink containing shellac, propylene glycol and red iron oxide (E172)|
What Pylera is and What it is Used For
Pylera contains 3 different active ingredients: bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride. Tetracycline and metronidazole belong to a group of medicines called antibiotics. Bismuth subcitrate potassium helps the antibiotics treat the infection.
Pylera contains a group of medicines used to treat adult patients infected with Helicobacter pylori(H. pylori) who have or have had an ulcer. H. pylori is a bacteria found in the stomach lining.
Pylera should be taken together with a medicine called omeprazole. Omeprazole is a medicine that works by reducing the amount of acid that your stomach produces. Pylera, taken with omeprazole works together to treat the infection and reduce the inflammation of the stomach lining.
What You Need to know before you take pylera
Do not Take Pylera
- if you are pregnant or breast-feeding
- if you are less than 12 years of age
- if you suffer from kidney problems
- if you suffer from liver problems
- if you are allergic (hypersensitive) to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, tetracycline or any of the other ingredients in Pylera (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking Pylera.
Take Special Care with Pylera
- if you have to go for an x-ray as Pylera may affect the results of x-rays
- if you go for blood tests, as Pylera may affect the results of your blood tests
- if you have been told by your doctor that you have an intolerance to some sugars
Avoid the sun and using sun beds during treatment with Pylera as it can exaggerate the effects of the sun. Tell your doctor if you get sun burnt.
Children and Adolescents
Pylera capsules must not be given to children below the age of 12 and are not recommended in children 12 to 18 years of age.
Other Medicines and Pylera
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription.
In particular tell your doctor if you are taking or have recently taken any of the following medicines:
- lithium used to treat some mental illness
- medicines used to thin the blood or which prevent blood clotting (e.g. warfarin)
- phenytoin and phenobarbital for epilepsy
- methoxyflurane (an anaesthetic)
- other antibiotics, particularly penicillin
- supplements containing iron, zinc, sodium bicarbonate
- the combination of Pylera with other drugs that contain bismuth, used long term, may affect the nervous system
- busulfan and fluorouracil used for chemotherapy
- cyclosporin used to lower your body‟s immune reaction after transplants
- disulfiram used to treat people with drinking problems
- ranitidine used for indigestion and heartburn
- retinoids for skin disorders
- atovaquone to treat an infection of the lung
Do not take antacids containing aluminium, calcium or magnesium at the same time as Pylera.
Pylera with Food, Drink and Alcohol
Take Pylera with a full glass of water after meals and at bedtime (preferably after a snack).
Do not eat or drink any dairy products (such as milk or yoghurt) or drinks with added calcium, at the same time as Pylera capsules and throughout your treatment with Pylera, as they may affect the way Pylera works.
Do not drink any alcohol while taking Pylera and for at least 24 hours after finishing your treatment. Drinking alcohol when taking Pylera may cause unpleasant side effects, such as feeling sick (nausea), being sick (vomiting), stomach pain (abdominal cramps), hot flushes and headaches.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and Breast-Feeding
Do not take Pylera if you are pregnant, might become pregnant during treatment or think you may be pregnant. Speak to your doctor if you become pregnant while taking Pylera.
Do not breast-feed while you are taking Pylera. This is because small amounts of the components of Pylera may pass into the breast milk.
Driving and Using Machines
Do not drive or use any tools or machines if you feel dizzy, sleepy, have fits (convulsions) or experience temporary blurred or double vision.
Pylera Contains Lactose and Potassium
Pylera contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Pylera contains approximately 96 mg of potassium per dose (3 capsules containing 32 mg of potassium each). To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
HOW TO TAKE PYLERA
Always take this medicine exactly as your doctor has told you. Pylera should be taken together with a medicine called omeprazole. Check with your doctor or pharmacist if you are not sure.
Adults and the Elderly
Take 3 Pylera capsules after breakfast, 3 capsules after lunch, 3 capsules after your evening meal and 3 capsules at bedtime (preferably after a snack), a total of 12 capsules per day. Swallow the capsules whole with a full glass of water to avoid any irritation to the throat. It is important to finish the complete course of treatment (10 days) and to take all 120 capsules.
Take one omeprazole 20 mg capsule/tablet with the breakfast and evening doses of Pylera (total of 2 omeprazole capsules/tablets per day).
Daily dosing schedule for Pylera
|Time of dose||Number of capsules of Pylera||Number of capsules/tablets of omeprazole|
|After evening meal||3||1|
|At bedtime (preferably after a snack)||3||0|
If You Take More Pylera than You Should
If you take more than the recommended dose of Pylera per day, then you should tell your doctor or go to your nearest hospital emergency department. Take the bottle and any remaining capsules with you. This is so that the doctor knows what you have taken.
If You Forget to Take Pylera
If you forget to take Pylera, 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 a forgotten dose.
If you miss more than 4 consecutive doses of Pylera (1 day), contact your doctor.
If You Stop Taking Pylera
It is important that you finish the full course of treatment even if you begin to feel better after a few days. If you stop taking Pylera too soon, your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to tetracycline and/or metronidazole (antibiotics).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Pylera and contact a doctor or go to a hospital immediately if you develop or notice any of the following:
- swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing.
- an itchy, lumpy rash (hives) or nettle rash (urticaria).
These could be signs of an allergic reaction.
- Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), Dug reaction with Eosinophilia and Systemic Symptoms (DRESS)) (See below
“Not Known” sides effects).
Other Possible Side Effects
Very common (may affect more than 1 in 10 people):
- changes in consistency or colour of your faeces including dark coloured faeces (black stools)
- bad or metallic-taste
Common (may affect up to 1 in 10 people):
- abdominal pain
- dry mouth
- passing wind /abdominal gas
- feeling weak
- feeling low in energy or tired
- feeling generally unwell
- vaginal infection – symptoms include itching and irritation in the genital area, burning sensation or yellowish / white vaginal discharge
- blood tests may show increased levels of liver enzymes (transaminases)
- dark-coloured urine
- loss or decreased appetite
- feeling dizzy / light-headed feeling
- feeling sleepy
- skin problems such as redness (rash)
Uncommon (may affect up to 1 in 100 people)
- allergic reaction to the drug (symptoms include swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing, or an itchy, lumpy rash (hives) or nettle rash (urticaria))
- feeling bloated / swollen abdomen
- burping or belching
- open sore inside the mouth / mouth ulcers
- changes in the colour of your tongue (dark tongue)
- swollen tongue
- chest pain, chest discomfort
- yeast (candida) infections, which can occur in the mouth (symptoms include white spots in the mouth) or in the genitals (symptoms including severe itching, burning sensation, soreness)
- tingling / pins and needles
- feeling anxious, depressed or difficulty sleeping
- memory disturbance
- skin problems such as itching or hives (urticaria)
- blurred (hazy) vision
- vertigo (head spinning)
Not Known (cannot be estimated from the available data):
- Serious illness with blistering of the skin, mouth, eyes and genitals (Steven-Johnson syndrome)
- Serious illness with blistering of the skin (Lyell syndrome, Toxic epidermal necrolysis)
- Flu-like symptoms, rash on the face then extended rash with a high temperature, increased levels of liver enzymes seen in blood tests, increase in a type of white blood cell (eosinophilia), enlarged lymph nodes (DRESS)
- Blistering (bubbles on the skin) and exfoliation of the skin (skin peeling)
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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Pylera
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture.
Do not throw away 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.
Contents of the Pack and Other Information
What Pylera Contains
The active substances are bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride. Each capsule contains 140 mg of bismuth subcitrate potassium (equivalent to 40 mg bismuth oxide), 125 mg of metronidazole and 125 mg of tetracycline hydrochloride.
The other ingredients are: magnesium stearate (E572), lactose monohydrate, talc (E553b), titanium dioxide (E171), gelatin and printing ink containing shellac, propylene glycol and red iron oxide (E172).
This medicine contains lactose and potassium.
What Pylera Looks Like and Contents of the Pack
Pylera capsules are elongated, white, opaque hard capsules with Aptalis Pharma logo printed on the body and „BMT‟ printed on the cap in red. They contain a white powder plus a smaller white, opaque capsule containing a yellow powder.
Pylera capsules are available in high density polyethylene bottles of 120 capsules.
A desiccant (silicon pack) and rayon coil are included in the bottle to help keep your medicine dry. Do not eat the desiccant or rayon coil.
Marketing Authorisation Holder and Manufacturer
Aptalis Pharma SAS Route de Bû
78550 Houdan, France
Tel: +33 1 30 46 19 00