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PYLERA 140 MG/125 MG/125 MG CAPSULES

Active substance(s): BISMUTH SUBCITRATE POTASSIUM / METRONIDAZOLE / TETRACYCLINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Pylera 140 mg/125 mg/125 mg capsules
bismuth subcitrate potassium
metronidazole
tetracycline hydrochloride
Read all of this leaflet carefully before you start taking Pylera because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Pylera is and what it is used for
What you need to know before you take Pylera
How to take Pylera
Possible side effects
How to store Pylera
Contents of the pack and other information

1.

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.
2.

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.
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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.

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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.
3.

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
After breakfast
After lunch
After evening meal
At bedtime (preferably after a
snack)

Number of capsules of
Pylera
3
3
3
3

Number of capsules/tablets
of omeprazole
1
0
1
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.

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4.

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)
• diarrhoea
• nausea
• bad or metallic-taste
Common (may affect up to 1 in 10 people):
• abdominal pain
• constipation
• dry mouth
• vomiting
• passing wind /abdominal gas
• headache
• 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)
• numbness
• tingling / pins and needles
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trembling
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 WKH Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information
on the safety of this medicine.
5.

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.
6.

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. See section 2.
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.
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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
5/6 place de l’Iris – La Défense 5
92400 Courbevoie, France
Tel: +33 1 70 82 16 30
This medicinal product is authorised in the Member States of the EEA under the following
names:
Belgium: Tryplera
Austria, Bulgaria, Czech Republic, Ireland, Germany, Greece, Hungary, France, Italy, Poland,
Portugal, Slovakia, Spain, United Kingdom: Pylera
This leaflet was last revised in 02/2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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