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PARMID XL 10MG PROLONGED RELEASE TABLETS

Active substance: FELODIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ0000LT000

Parmid® XL 5 mg and 10 mg Prolonged Release Tablets
Felodipine
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
effect not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Parmid XL is and what it is used for
2. What you need to know before you take
Parmid XL
3. How to take Parmid XL
4. Possible side effects
5. How to store Parmid XL
6. Content of the pack and other information

1






phenytoin (medicine to treat epilepsy)
carbamazepine (medicine to treat epilepsy)
rifampicin (medicine to treat infections)
barbiturates (medicine to treat anxiety, sleeping
problems and epilepsy)
• tacrolimus (medicine used in organ
transplantations)

What Parmid XL is and what it is
used for

Parmid XL Prolonged Released Tablets (referred
as Parmid XL throughout this leaflet) contains the
active substance felodipine. This belongs to a
group of medicines called calcium antagonists. It
lowers blood pressure by dilating small blood
vessels. It does not negatively affect the heart
function.

Medicines containing St John’s wort (Hypericum
perforatum) (herbal product used to treat
depression) may reduce the effect of Parmid XL
and should therefore be avoided.

Parmid XL is used in the treatment of high blood
pressure (hypertension) and heart and chest pain
brought on by for example exercise or stress
(angina pectoris).

2

Parmid XL with food and drink
Do not drink grapefruit juice if you are treated with
Parmid XL, as this may increase the effect of
Parmid XL and the risk of side effects.
Pregnancy and breast-feeding
Pregnancy
Do not take Parmid XL if you are pregnant.

What you need to know before you
take Parmid XL

Breast-feeding
• Tell your doctor if you are breast-feeding or
about to start breast-feeding. Parmid XL is not
recommended for mothers who are
breast-feeding, and your doctor may choose
another treatment for you if you wish to
breast-feed.

Do not take Parmid XL
• if you are allergic to felodipine or any of the
other ingredients of this medicine (listed in
section 6).
• if you have acute myocardial infarction (heart
attack).
• if you have chest pain of recent onset, or
angina pectoris that is lasting for more than
15 minutes or longer or is more severe than
usual.
• if you suffer from uncompensated heart failure.
• if you have disease of a heart valve or heart
muscle, until you have talked to your doctor.
• if you are pregnant. You should tell your doctor
as soon as possible if you become pregnant
while using this medicine.

Driving and using machines
Parmid XL can have minor or moderate influence
on your ability to drive and use machines. If you
experience headache, nausea, dizziness or
fatigue your ability to react may be impaired.
Caution is recommended especially at the start of
treatment.
Parmid XL contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicine.

Warnings and precautions
Parmid XL, like other blood-pressure lowering
medicinal products, may in rare cases lead to
pronounced low blood pressure which in some
patients may result in an inadequate supply of
blood to the heart. Symptoms of excessive low
blood pressure and inadequate blood supply to
the heart itself, frequently include dizziness and
chest pain. If you experience these symptoms,
seek emergency care immediately.

3

Always take this medicine exactly as your doctor
has told you. Check with your doctor if you are not
sure.

Talk to your doctor before taking Parmid XL,
especially if you have problems with your liver.

Parmid XL prolonged release tablets should be
taken in the morning and be swallowed with
water. The tablet must not be divided, crushed or
chewed. This medicine can be taken without food
or following a light meal not high in fat or
carbohydrates.

Taking Parmid XL may cause your gums to
become swollen. Practice good oral hygiene to
help avoid your gums from swelling (see section
4).

Hypertension
Treatment should be started with 5 mg once a
day. If necessary, your doctor may increase the
dose or add another blood-pressure lowering
medicine. The usual dose when treating this
disease for a long time is 5-10 mg once a day. In
elderly patients, a starting dose of 2.5 mg daily
may be considered.

Children
The use of Parmid XL is not recommended in
children.
Other medicines and Parmid XL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. Some medicines/herbal remedies can
affect treatment with Parmid XL.

For a dose of 2.5 mg a medicinal product with an
appropriate strength should be used.

Examples are:
• cimetidine (medicine to treat gastric ulcers)
• erythromycin (medicine to treat infections)
• itraconazole (medicine to treat fungi)
• ketoconazole (medicine to treat fungi)
• medicines to treat HIV protease inhibitors (such
as ritonavir)
• medicines to treat HIV infection (such as
efavirenz, nevirapine)

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How to take Parmid XL

Stable angina pectoris
Treatment should be started with 5 mg once a day
and if needed, your doctor may increase the dose
to 10 mg once a day.

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Artwork Proof Box
Ref: V052 - update outcome of Art. 30 ref + revised date
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Date prepared:
22/04/2015

Colours:
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Dimensions: 165 x 420 mm

Font size:
9pt
Fonts:
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If you have liver problems
The level of felodipine in your blood may be
increased. Your doctor may lower the dose.

effects not listed in this leaflet. You can also report
side effects directly via Yellow Card Scheme:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

Elderly people
Your doctor may initiate treatment with the lowest
available dose.
If you take more Parmid XL than you should
If you take more than the recommended number
of doses of Parmid XL, you may suffer from very
low blood pressure and sometimes palpitations,
high or, rarely, slow heart rate. Therefore, it is very
important that you take the number of doses
prescribed by your doctor. If you experience
symptoms such as feeling faint, light-headedness
or dizziness, contact your doctor immediately.

How to store Parmid XL

Keep this medicine out of the sight and reach of
children.
Do not use Parmid XL after the expiry date “EXP”
which is stated on the packaging. The expiry date
refers to the last day of that month.
Do not store above 25°C.
Shelf life in blisters: 4 years.

If you forget to take Parmid XL
If you forget to take a tablet, leave out that dose
completely. Take your next dose at the right time.
Do not take a double dose to make up for a
forgotten dose.

Do not throw away any medicine via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

If you stop taking Parmid XL
If you stop taking this medicine your condition
may return. Please consult your doctor and seek
advice before you stop taking Parmid XL. Your
doctor will advise you how long to take your
medicine.

6

Contents of the pack and other
information

What Parmid XL contains
• The active substance is felodipine. One
prolonged release tablet contains 5 mg or
10 mg of felodipine.
• The other ingredients are: lactose
monohydrate, microcrystalline cellulose,
hydroxypropylmethylcellulose, magnesium
stearate, sodium lauryl sulphate, macrogol
4000, titanium dioxide (E171), iron oxide yellow
(E172), iron oxide red (E172).

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4

5

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the following happen to you, stop taking
Parmid XL and tell a doctor straight away:
• Hypersensitivity and allergic reactions: The
signs may include raised lumps on your skin
(weals) or swelling of your face, lips, mouth,
tongue or throat.

What Parmid XL looks like and contents of the
pack:
Parmid XL 5 mg Tablets are round, pale red to
grey-red, biconvex film-coated tablet with
embossment “F5”.
Parmid XL 10 mg Tablets are round, pale red to
grey-red, biconvex film-coated tablet with
embossment “F10”.

The following undesirable effects have been
identified. Most of these reactions appear at start
of treatment or after a dose increase. Should such
reactions occur, they are usually brief and
diminish in intensity with time. If you experience
any of the following symptoms and they persist,
please tell your doctor.

Your tablets come in
• original packs of 10, 20, 28, 30, 50, 56, 100 or
100 x 1 prolonged release tablets.
Not all pack sizes may be marketed.

Mild enlargement of the gums has been reported
in patients with an inflammation in the mouth
(gingivitis/periodontitis). The enlargement can be
avoided or reversed by careful oral hygiene.

Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Very common: may affect more than 1 in 10
people
• Ankle swelling.

Manufacter:
Salutas Pharma GmbH, Otto-von-Guericke-Allee
139179, Barleben, Germany or
Salutas Pharma GmbH, Dieselstrasse 5D-70839,
Gerlingen, Germany.

Common: may affect up to 1 in 10 people
• Flushing
• Headache

This leaflet was last revised in 04/2015.

Uncommon: may affect up to 1 in 100 people
• Abnormally rapid heart rate
• Palpitations
• Too low blood pressure (hypotension)
• Nausea
• Abdominal pain
• Burning/prickling/numbness
• Rash or itching
• Fatigue
• Dizziness
Rare :may affect up to 1 in 1,000 people
• Nettle rash
• Fainting
• Vomiting
• Pain in jointsMuscular pain
• Impotence/sexual dysfunction
Very rare: may affect up to 1 in 10,000 people
• Gingivitis (swollen gums)
• Increased liver enzymes
• Skin reactions due to increased sensitivity to
sunlight
• Inflammation of small blood vessels of the skin
• A need to pass water frequently
• Hypersensitivity reactions such as fever or
swelling of the lips and tongue
Other undesirable effects may occur. If you have
any bothersome or unusual reaction while taking
Parmid XL, check with your doctor right away.

draft: 44046640, 44046641
laetus code: 0000
mat.no.: 00000000

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side

00000000
SZ00000LT000

Artwork Proof Box
Ref: V052 - update outcome of Art. 30 ref + revised date
Proof no.
006.1

Date prepared:
22/04/2015

Colours:
Black
Dimensions: 165 x 420 mm

Font size:
9pt
Fonts:
Helvetica

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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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