Skip to Content

PIVMECILLINAM HYDROCHLORIDE 200 MG FILM-COATED TABLETS

Active substance(s): PIVMECILLINAM HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, 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. What Pivmecillinam hydrochloride is and what it is used for
2. What you need to know before you take Pivmecillinam
hydrochloride
3. How to take Pivmecillinam hydrochloride
4. Possible side effects
5. How to store Pivmecillinam hydrochloride
6. Contents of the pack and other information
1. What Pivmecillinam hydrochloride is and what it is used for
Pivmecillinam belongs to a group of medicines called penicillins. It
is a type of antibiotic.
Pivmecillinam works by killing germs (bacteria) that cause
infections.

P150xxxxx

P150xxxxx

Pivmecillinam
hydrochloride

Package leaflet: Information for the user

Pivmecillinam hydrochloride 200 mg film-coated tablets
pivmecillinam hydrochloride

Pivmecillinam
hydrochloride

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Other medicines and Pivmecillinam hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Tell your doctor or pharmacist if you use any of the following
medicines:
Ÿ
Probenecid (for treating gout). This may increase the effect of
Pivmecillinam hydrochloride.
Ÿ
Methotrexate (for treating rheumatism, cancer). The excretion of
methotrexate from your body may be slower when used
together with Pivmecillinam hydrochloride.
Ÿ
Valproate or valproic acid (for treating epilepsy). This increases
the risk of too little carnitine in your body when used together
with Pivmecillinam hydrochloride.
Ÿ
Other antibiotics (e.g. tetracyclines, erythromycin, other betalactam antibiotics). This can influence the effect. of
Pivmecillinam hydrochloride.
Pivmecillinam hydrochloride with food and drink
You can take your medicine with or immediately after a meal. You
must take Pivmecillinam hydrochloride with at least half a glass of
water. It is important to take your medicine with plenty of liquid and
in good time before bedtime. This will stop you getting any
problems in your food pipe.
Pregnancy, breast-feeding and fertility
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.
Pregnancy
Pivmecillinam hydrochloride can be taken during pregnancy.

Pivmecillinam hydrochloride is used to treat infections of the
bladder (cystitis) in adults.

Breast-feeding
Pivmecillinam hydrochloride can be taken during breast-feeding.

2. What you need to know before you take Pivmecillinam
hydrochloride

Fertility
Ÿ
Clinical studies concerning fertility have not been done.

Your doctor may have prescribed a different use or dosage than
stated in this information. Always follow your doctors instructions.

Driving and using machines
Pivmecillinam hydrochloride has no or negligible influence on your
ability to drive or use machines.

Do not take Pivmecillinam hydrochloride
Ÿ
If you are allergic to pivmecillinam or any of the other
ingredients of this medicine (listed in section 6).
Ÿ
If you are allergic to other antibiotics. Such antibiotics include
penicillin or cephalosporins.
Ÿ
If you have narrowing of the food pipe.
Ÿ
If you suffer from a condition which may reduce the amount of a
substance called carnitine in your body. Such conditions include
carnitine transporter defect, methylmalonic aciduria and
propionic acidaemia
Warnings and precautions
Talk to your doctor or pharmacist before taking Pivmecillinam
hydrochloride. The tablets must be taken with at least half a glass
of fluid to prevent that the tablets get stuck in your food pipe.
Before you take Pivmecillinam hydrochloride tell your doctor:
Ÿ
If you have porphyria.
Ÿ
If you have already used Pivmecillinam hydrochloride recently,
as use for a longer period may reduce the amount of carnitine in
your body.
During treatment:
Ÿ
If you suddenly have diarrhoea while taking Pivmecillinam
hydrochloride tell your doctor immediately. This may be
because your bowel is inflamed (colitis).
Children and adolescents
Do not give this medicine to children and adolescents below 18
years because the potential benefits may not be greater than the
risks.

Black

3. How to take Pivmecillinam hydrochloride
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you. Check with your doctor,
pharmacist if you are not sure. You should take the medicine at
equally spaced times in the day. When you have to take it three
times a day, take it at breakfast, at lunch and then at dinner time.
Pivmecillinam hydrochloride must be taken with at least half a glass
of liquid. Your doctor will tell you how long you need to use
Pivmecillinam hydrochloride tablets.
The usual dose is 200 mg two times daily for 7 days, alternatively
200 mg 3 times daily for 5 days.
Paediatric population:
Pivmecillinam hydrochloride should not be used in children and
adolescents below 18 years because the efficacy and safety have
not yet been established.
Elderly: Dose adjustment is not necessary.
If you have reduced kidney function or reduced liver function dose
adjustment is not necessary.
Take this tablet as follows:
1. Do not push the tablet
Do not push against the tablet pocket.

2. Tear off one tablet pocket
Bend and tear off one tablet pocket along the dotted lines.

3. Peel off the lid
Lift, hold and peel off the lidding foil, starting from the side indicated
by the arrow.

Mouth or food pipe ulcer, inflammation of the food pipe
Ÿ
Ÿ
Liver function disorders
Ÿ
Changes in blood or liver values
Ÿ
Muscle weakness or muscle loss. Tiredness or lack of energy.
Too little carnitine in your body may cause these symptoms.
Ÿ
Nettle rash
Ÿ
Itching
Ÿ
Fatigue
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
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 Pivmecillinam hydrochloride

If you take more Pivmecillinam hydrochloride than you should
Tell your doctor straight away. You may need to stop taking this
medicine.
You may be sick, or feel sick, or get an upset stomach.
If you forget to take Pivmecillinam hydrochloride
If you forget to take your medicine, take it as soon as you
remember. Always take it with at least half a glass of water or other
liquid. Then take the next dose at the usual time.
If you stop taking Pivmecillinam hydrochloride
It is very important to take all the medicine that your doctor has told
you to take. You must finish this medicine even if you feel better.
You must do this because otherwise you may feel ill again.
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.
The most serious side effects:
Uncommon: may affect up to 1 in 100 people.
Ÿ
Sudden skin rash, the face and/or the throat swell, breathing
difficulty or fainting due to hypersensitivity (anaphylactic
reaction). Seek medical help immediately as you may need
urgent medical treatment.
Ÿ
Severe and lasting bloody diarrhoea with stomach pain and
fever (pseudomembranous colitis). Seek medical help
immediately as you may need urgent medical treatment.
Ÿ
Bleeding from skin and mucous membranes and bruising of the
skin due to changes in the blood (low platelet count)
(thrombocytopenia). Contact your doctor.
Other side effects:
Common: may effect upto 1 in 10 people
Ÿ
Fungal infection of the vagina Feeling.
Ÿ
Diarrhoea.
Ÿ
Feeling sick (nausea).
Uncommon: may effect upto 1 in 100 people
Ÿ
Headache
Ÿ
Dizziness
Ÿ
Being Sick (Vomoting)
Ÿ
Stomach Pain

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on
the carton after EXP. The expiry date refers to the last day of that
month.
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 Pivmecillinam hydrochloride contains
- The active substance is pivmecillinam hydrochloride. Each filmcoated tablet contains 200 mg of pivmecillinam hydrochloride.
- The other ingredients are:
Tablet core: Cellulose microcrystalline, magnesium stearate.
Film coating: Hypromellose, triacetin.
What Pivmecillinam hydrochloride looks like and contents of
the pack
Film-coated tablet.
White to off-white, round shaped, biconvex, film coated tablets
debossed with 'F' on one side and '48' on the other side.
Pivmecillinam hydrochloride film-coated tablets are available in
PVC/OPA/aluminum/PVC/Paper/PET/aluminum foil blister pack.
Pack sizes: 2, 10, 14 and 100 film-coated tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 09/2015.

P150xxxxx

4. Remove the Tablet with dry hands and take as directed
above.

Expand view ⇕

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.

Hide