Skip to Content

PARMID XL 2.5MG PROLONGED-RELEASE TABLETS

Active substance: FELODIPINE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Parmid® XL 2.5 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 effects 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. Contents of the pack and other information

1

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.

What Parmid XL is and what it is
used for

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.

Parmid XL 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.

Pregnancy and breast-feeding
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

Pregnancy
Do not take Parmid XL if you are pregnant.
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.

What you need to know before you
take Parmid XL

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.

3

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.

How to take Parmid XL

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

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

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.

Taking Parmid XL may cause your gums to become
swollen. Practice good oral hygiene to help avoid
your gums from swelling (see section 4).
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.
Examples are:
• cimetidine (medicine to treat gastric ulcers)
• erythromycin (medicine to treat infections)
• itraconazole (medicine to treat fungi)
• ketoconazole (medicine to treat fungi)
• protease inhibitors to treat HIV infection (such as
ritonavir)
• medicines to treat HIV infection (such as efavirenz,
nevirapine)
• 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)

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.
If you have liver problems
The level of felodipine in your blood may be
increased. Your doctor may lower the dose.
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.

Continued over the page >>

draft: 44031168
laetus code: 00000
mat.no.: 00000000

00000000

Artwork Proof Box
Ref: V008: Update Art 30 + Day 20 + post approval corrections
Proof no.
003.2

Date prepared:
03/07/2015

Colours:
Black
Black 20%
Dimensions: 165 x 420 mm

Font size:
8.5pt
Fonts:
Helvetica

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.

6

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.

What Parmid XL contains
• The active substance is felodipine. One
prolonged-release tablet contains 2.5 mg of
felodipine.
• The other ingredients are:
Tablet core: lactose monohydrate, sodium
laurilsulfate, hypromellose, microcrystalline
cellulose, magnesium stearate.
Tablet coating: lactose monohydrate,
hypromellose, titanium dioxide (E171), macrogol
4000, iron oxide, yellow (E172).

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

4

Contents of the pack and other
information

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

What Parmid XL looks like and contents of the
pack
Parmid XL Prolonged-release Tablets are round,
pale yellow, biconvex film-coated tablets;
embossment “2.5” on one side of the tablet.

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.

Your tablets come in
• blister packs of 7, 14, 20, 28, 30, 50, 56, 60, 100
and 112 prolonged-release tablets.
• plastic containers of 100 and 250 prolongedrelease tablets.

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.

Not all pack sizes and pack types may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

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.

Manufacturer
Salutas Pharma GmbH Otto-von-Guericke-Allee 1,
39179 Barleben, Germany

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

or

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

Lek Pharmaceuticals d.d. Verovškova 57, 1526
Ljubljana, Slovenia

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

or
LEK S.A, ul. Podlipie 16, 95-010 Stryków, Poland
or
LEK S.A, ul. Domaniewska 50 C, 02-672 Warsaw,
Poland

Rare: may affect up to 1 in 1,000 people
• Nettle rash
• Fainting
• Vomiting
• Pain in joints
• Muscular pain
• Impotence/sexual dysfunction

This leaflet was last revised in 07/2015.

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 reactions while taking
Parmid XL, check with your doctor right away.
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
(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 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.
This medicinal product does not require any special
storage conditions.
Plastic container:
Do not store above 25°C after first opening. Shelf-life
after first opening: 6 months.

draft: 44031168
laetus code: 00000
mat.no.: 00000000

00000000
SZ00000LT000

Artwork Proof Box
Ref: V008: Update Art 30 + Day 20 + post approval corrections
Proof no.
003.2

Date prepared:
03/07/2015

Colours:
Black
Black 20%
Dimensions: 165 x 420 mm

Font size:
8.5pt
Fonts:
Helvetica

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