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PRIMALAN 5MG TABLETS

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PROPOSED-PL 05630/0023-0004 (responses 21.11.2012)
360 x 210 mm • Corps : 8 pt (9 pt Times New Roman) • Interligne :
EN ACCORD AVEC LA NOUVELLE GUIDELINE 2011 - UK
PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

Primalan

5mg Tablets

Mequitazine
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 further questions, please ask your
doctor or your 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.
What is in this leaflet
1. What Primalan is and what it is used for
2. What you need to know before you take Primalan
3. How to take Primalan
4. Possible side effects
5. How to store Primalan
6. Contents of the pack and other information

1. What Primalan is and what it is used for
Pharmacotherapeutic group: Antihistamines for systemic
use.
ATC code: R06AD07 Mequitazine
Primalan belongs to a group of medicines called
antihistamines that act by blocking the body’s response
to histamine release and so reducing the allergic
reaction.
If you come into contact with something that you
are allergic to, your body responds by producing a
substance called histamine. This triggers a number of
different reactions in your body. These may include
itchy, runny nose as in hayfever and nasal allergies
(which occur at any time of the year e.g. due to
animal fur or house dust mites), itchy skin conditions
and allergic reactions associated with insect bites and
stings.
If you need any further information on your condition,
please ask your doctor.

2. What you need to know before you take
Primalan
Do not take Primalan if you
• are sensitive or allergic to the active substance or
any of the other ingredients, particularly lactose,

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• if you are taking other medicines known to cause
changes to the electrocardiogram (ECG), especially
medicines known to cause “QT interval prolongation”,
for example, certain types of heart medication
belonging to the antiarrhythmic class of drugs,
sotalol, certain antibiotics, IV vincamine, diphemanil or
mizolastine (see «Other medicines and Primalan»),
• if you suffer from certain abnormal congenital ECG
changes known as “congenital long QT syndrome”,
• if you have low blood potassium levels (hypokalaemia),
• if you have a slow heart rate,
• are sensitive to phenothiazines which are usually
used to treat psychiatric illness, severe agitation or
anxiety. From your sensitivity you may have suffered
from agranulocytosis (considerable reduction in white
blood cell levels).
• are taking or have taken drugs called monoamine
oxidase inhibitors (MAOIs) within the last 14 days
which are usually used to treat depression or
Parkinson’s disease,
• suffer from a condition called porphyria (a group of
conditions which may be associated with abdominal
symptoms such as pain and vomiting, problems with
the nerves which may lead to weakness or paralysis,
abnormal thoughts, skin lesions on exposure to
sunlight and dark urine),
• have glaucoma (increased pressure in the eye),
• are suffering from or at risk of urinary retention
(difficulty in passing urine).
If you are unsure of anything, it is essential that you
ask your doctor or pharmacist for advice.
Take special care with Primalan
Special warnings
• If you suffer from palpitations or irregular heart rate,
or experience malaise with loss of consciousness
during treatment, tell your doctor immediately.
Your doctor may carry out an electrocardiogram
(ECG) to check your heart.
• If you have asthma.
• If you develop a fever during treatment, with or
without signs of infection (sore throat, etc.) contact
your doctor quickly for advice and possible treatment.
• Use of Primalan is not recommended in patients
taking certain medicines (see section «Other
Medicines and Primalan»).
• You are advised to AVOID drinking alcohol and
taking other medicines which contain alcohol when
taking Primalan.
Precautions for use
Before taking this medicine tell your doctor
• If you have any liver problems or suffer from chronic
liver disease discuss your treatment dose with your
doctor,
• If you suffer from epileptic fits,
• If you have an enlarged prostate or any other
prostate disorder,

• If you are elderly because you are more susceptible
to the side-effects such as constipation, feeling
tired, drowsy, thirsty and the hypotensive (low blood
pressure) effects.
Exposure to the sun should preferably avoided during
treatment owing to the risk of photosensitivity reactions.
If you are unsure of anything, ask your doctor or
pharmacist for advice.
If you have to go to a doctor, dentist or hospital for
any reason, take all your medicines with you, including
Primalan.
Other medicines and Primalan
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Some medicines may interact with Primalan potentially
giving unwanted side effects and some of these
medicines should not be given with Primalan. Speak
to your doctor if you are taking any of the medicines
listed below.
• heart medications (amiodarone, bepridil, disopyramide,
dronedarone, hydroquinidine, dofetilide, ibutilide, sotalol,
quinidine),
• certain antibiotics (IV erythromycin, IV spiramycin,
moxifloxacin),
• drugs used for gastro-oesophageal reflux, cisapride,
• certain antiallergic agents (diphemanil, mizolastine), IV
vincamine,
• products containing arsenic, toremifene, or IV dolasetron.
• drugs used to eradicate parasites (halofantrine,
lumefantrine, pentamidine),
• certain antipsychotic agents (amisulpride, chlorpromazine,
cyamemazine, droperidol, flupentixol, fluphenazine,
haloperidol, levomepromazine, pimozide, pipamperone,
pipotiazine, sertindole, sulpiride, sultopride, tiapride,
zuclopenthixol),
• methadone, a medicine used during opiate withdrawal.
• drugs used to treat depression (e.g. imipramine,
paroxetine, fluoxetine, duloxetine, bupropion),
• drugs used to treat the inability to control urination
(e.g. oxybutynin),
• drugs used to treat Parkinson’s disease, which is a
disorder of the brain causing limb stiffness, tremor
and slow movement, and is usually seen in older
people (e.g. trihexyphenidyl, benzatropine, rasagiline),
• drugs which make the airways open up and
become bigger in chest disorders like asthma or
chronic bronchitis (e.g ipratropium),
• drugs used to relieve nasal congestion (e.g. ephedrine),
• drugs used to relieve cramps or spasms of the
stomach, intestines or bladder (known as antispasmodic
drugs, e.g. mebeverine),
• drugs used to dilate the pupil of the eye for
examination (e.g.tropicamide),

• drugs used to control anxiety (‘anxiolytic’ drugs, e.g.
alprazolam) and to help you sleep if you suffer from
insomnia (‘hypnotics’ e.g. zolipdem, nitrazepam).
• drugs used to treat fungal infections (terbinafine),
• drugs used to treat thyroid problems (cinacalet).
This medicine contains the antihistamine mequitazine.
Other medicines also contain anthistamines.
It is important to avoid exceeding the maximum
recommended dose, do not take them at the same
time as this medicine (see “Dosage” in section 3).
Taking Primalan with food, drink and alcohol
Consumption of alcohol
As Primalan may increase the sedative effects of
alcohol you are advised to avoid drinking alcohol whilst
taking these tablets.
Primalan can be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
Pregnancy
The use of Primalan in pregnant women is limited.
Primalan is NOT recommended during the first three
months of pregnancy. If necessary your doctor may
prescribe Primalan for limited use during the last three
months of your pregnancy.
If this happens it may be necessary to monitor the
effects on your new born baby.
Breast-feeding
It is unknown whether Primalan is excreted in human
breast milk. As it is not known whether this is harmful
to your baby, this should be discussed with your doctor
whether to take this medicine or not.
Driving and using machines
As Primalan can make you drowsy, your level of
alertness may be impaired making driving or machine
use dangerous. The drowsiness associated with the use
of this medicine is increased by the consumption of
alcoholic drinks, other medicines which contain alcohol
and antihistamines which might be in another medicine
which you could be taking.
Therefore, you should be responsible and assess and
check your own personal responses before driving or
operating machinery.

21/11/12 14:49

3. How to take Primalan
Dosage
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
For use in Adults and children over the age of
12 years only
Do not exceed the recommended dose.
Adults
The usual dose is one 5 mg tablet to be taken orally
twice a day, although in elderly patients (over 65 years)
caution should be used.
Children 12 years of age and over
One 5 mg tablet to be taken twice a day.
Primalan is not recommended in children under 12
years of age
Elderly
Due to the possible sedative effect of this medicine
especially in the elderly it may be preferable to take
this medicine in the evening. Your doctor will advise
you.
Method of administration
Oral use. The tablets should be swallowed with a glass
of water.
Frequency of administration
Do not exceed the daily dose.
Due to the possible sedative effects it may be
preferable to take this medicine in the evening.
Duration of treatment
Follow your doctor’s prescription.
If you take more Primalan than you should
If you accidentally take too many tablets, or if a child
takes a tablet, contact your nearest hospital emergency
department or tell your doctor immediately.
The main overdose symptoms are increased heart rhythm
disorders, nausea, vomiting, seizure, difficulty in passing
urine, constipation, mouth dryness, feeling dizzy or
faint, drowsiness, sedation or coma. If you have taken
too many tablets, consult your doctor or pharmacist
immediately for advice.
In children, the extrapyramidal symptoms may occur in
case of overdosage.
If you forget to take Primalan
Do not worry, just take the tablet as soon as you
remember, then continue as before. Do not take a
double dose to make up a forgotten dose.

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If you stop taking Primalan
There are no risks if you do not take the fully
prescribed course of treatment from your doctor.

4. Possible side effects
Like all medicines, Primalan can cause side effects,
although not everybody gets them.
All medicines can cause allergic reactions although
serious allergic reactions are rare. Any sudden
wheeziness, difficulty in breathing, swelling of the
eyelids, face or lips, rash or itching (especially affecting
your whole body) should be reported to a doctor
immediately.
In rare cases, serious blood disorders affecting the
blood cells may result causing symptoms such as fever,
sore throat and painful mouth ulcers.
Some patients may experience ECG changes such as
QT interval prolongation, which is delayed electrical
conduction changes within your heart with symptoms
such as an increase in your heartbeat, irregular heart
beat and palpitations.
If you experience these, stop taking Primalan and
contact your doctor immediately.
The following side effects have also been reported:
• Skin problems - itch, redness, raised wheals (nettle
rash), dry eczema rash and sensitivity to sunlight/
sunlamps
• Small violet spots in the skin which do not fade on
pressure (purpura)
• Drowsiness, reduced alertness confusion and
hallucinations, i.e. imagining sensations (particularly in
the elderly)
• Dryness of the mouth
• Constipation
• Difficulty or pain passing urine, urinary retention,
• Problems with vision, e.g. blurring
• Chest tightness and awareness of the heart beating
(tachycardia).
• Problems with co-ordination
• Muscle rigidity, tremor and/or abnormal movements
• Nervousness, agitation and excitation
• Difficulty in sleeping
• Headache
• Low blood pressure (you may feel dizzy or faint)
If any of these become serious, or you notice any
side effects not listed in this leaflet, please tell your
doctor.

5. How to store Primalan
Keep out of the sight and reach of children.
Storage conditions
Do not use Primalan after the expiry date which is
stated on the blister and box (after Exp). The expiry
date refers to the last day of that month.
Do not store above 25 °C. Store in the original

container in order to protect from light.
Do not throw away any medicines via wastewater. Ask
your pharmacist how to throw away medicines you
no longer use. These measure will help protect the
environment.

6. Contents of the pack and other
information
What Primalan 5 mg Tablets contains
The active substance is mequitazine.
The other ingredients are Lactose, Maize starch,
Colloidal silicon dioxide (E551), Magnesium stearate and
Microcrystalline cellulose (E460).
Each tablet contains 5 mg of mequitazine.
What Primalan looks like and contents of the pack
Primalan is a round white or almost white tablet, 9
mm in diameter, with a flat faced bevel-edge with two
score-lines on one face. The score-lines can be used
to divide the tablet into equal halves which is useful if
your doctor has given you specific dose instructions.
Primalan 5 mg Tablets are available in tablet containers,
in bottles containing 100 tablets, or in blister packs
containing 6, 56, 60 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Pierre Fabre Médicament
45, Place Abel-Gance - 92100 Boulogne - France.
Manufacturer:
Pierre Fabre Médicament Production
Etablissement Progipharm
Rue du Lycée - 45500 Gien, France.
For any information about this medicine, please contact
the local representative of the Marketing
Authorisation Holder:
Pierre Fabre Ltd. - Tel: 01962 874400
Other formats:
To listen to or request a copy of this leaflet in
Braille,
large print or audio call:

0800 198 5000
Please be ready to give the following information:
Product Name Reference Number
Primalan 5 mg Tablets: PL 05630/0028
This is a service provided by the Royal National
Institute of the Blind.
This leaflet was last updated in 11/2012.
000 000

Important information about some of the ingredients
of Primalan
Primalan contains a small amount of lactose (a sugar)
in each tablet. If you have been told by your doctor
that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

21/11/12 14:49

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