PROMETHAZINE HYDROCHLORIDE 25MG TABLETS

Active substance: PROMETHAZINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

PROMETHAZINE HYDROCHLORIDE
25 mg TABLETS
Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to take Promethazine
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more
information or advice.
- This medicine may not work as well if you take
it for more than 7 days.
- If any of the side effects become serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS
1. What Promethazine is for
2. Before you take Promethazine
3. How to take Promethazine
4. Possible side effects
5. How to store Promethazine
6. Further information

1. WHAT PROMETHAZINE IS FOR
The name of your medicine is Promethazine
Hydrochloride 25 mg Tablets (called Promethazine in
the leaflet). It can act as a sedative, an antihistamine
and an antiemetic.
Promethazine may be provided directly by a pharmacist
for use in the following situations:
to treat adults with short-term insomnia
(difficulty in sleeping)
to treat allergic conditions, such as hay fever or
rashes
to treat and prevent you feeling sick (nausea) or
being sick (vomiting), such as travel sickness.
Promethazine may also be given to you by a doctor.
This can be for use in any of the above situations or
for use in the following additional situations:
to help you feel more relaxed before an operation
as a short-term sedative for both adults and
children to calm you down or to induce sleep.

2. BEFORE YOU TAKE PROMETHAZINE
Do not take Promethazine and tell your
doctor if:
you are allergic to promethazine hydrochloride or
any of the other ingredients in the tablets (see
section 6 of this leaflet)
the person taking this medicine is under 2 years
old
you are taking a medicine for depression called a
monoamine oxidase inhibitor (MAOI) or you have
stopped taking one of these MAOI medicines
within the last 14 days
the person taking this medicine is unconscious
(in a coma) or suffers from severe dizziness,
drowsiness or headache.
Do not take this medicine if any of the above apply
to you. If you are not sure, talk to your doctor or
pharmacist before taking Promethazine.

Take special care with Promethazine
Tell your doctor or pharmacist before you take this
medicine if you:
have difficulty in breathing, wheezing, tightness
in the chest (asthma) or an infection in your
lungs (bronchitis)
have epilepsy
have any serious heart problems
have liver or kidney problems
have difficulty in passing urine
have an enlarged prostate gland
have a stomach blockage
have increased pressure in the eye (narrow
angle glaucoma)

have suffered from Reye's Syndrome or you
have signs of Reye's Syndrome, such a being
sick and confused after a viral illness.
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking
Promethazine.

Taking other medicines
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, even
medicines bought without a prescription. This is
because Promethazine can affect the way some
medicines work. Also some medicines can affect the
way Promethazine works.
In particular, tell your doctor or pharmacist if you are
taking any of the following:
medicines for depression called monoamine
oxidase inhibitors (MAOIs), such as
moclobemide or you have stopped taking one of
these MAOI medicines within the last 14 days
other medicines for depression called tricyclic
antidepressants, such as amitriptyline or
dosulepin
medicines to help you to sleep or feel more
relaxed, such as diazepam or zolpidem
medicines to relieve pain, reduce fever or treat
arthritis, such as aspirin. Promethazine may hide
the side effects of these medicines
anticholinergic medicines. This includes some
medicines used for irritable bowel syndrome or
weak bladder, such as atropine or oxybutynin.
These can increase the risk of dry mouth, blurred
vision, constipation and difficulty in passing urine.

Tests
Taking Promethazine may affect the results of certain
tests. These include some pregnancy tests based on
urine samples and skin tests. Promethazine should
not be taken at least 3 days before the start of a skin
test.

Taking Promethazine with food and drink
Do not drink alcohol whilst taking Promethazine.
Alcohol may increase the sedative effects of
Promethazine and make you feel very sleepy.

Pregnancy and breast-feeding
Talk to your doctor before taking Promethazine if you
are pregnant or planning to become pregnant.
Promethazine should not be taken 2 weeks before
birth.
You should not take Promethazine if you are breastfeeding. This is because small amounts may pass
into the mothers' milk. This could be harmful to your
baby.
Follow the advice of your doctor or pharmacist before
taking any medicine.

Driving and using machines
You may feel drowsy or sleepy after taking this
medicine or the day after you have taken this medicine.
If this happens, do not drive or operate machinery.

Important information about some of the
ingredients of Promethazine tablets
This medicine contains lactose and sucrose (types
of sugars). If you know you have an intolerance to
some sugars contact your doctor or pharmacist
before taking Promethazine.

3. HOW TO TAKE PROMETHAZINE
If your doctor has prescribed this medicine, always
take Promethazine exactly as your doctor has told
you to. Otherwise, follow the instructions provided in
this leaflet. If you are not sure how much you need
to take talk to your doctor or pharmacist.

Taking this medicine
Swallow the tablets whole with a glass of water
This medicine may not work as well if you take it
for more than 7 days. If your symptoms worsen
or do not improve after 7 days talk to your doctor
or pharmacist.

How much to take
The usual dose is:

For allergies (such as hay fever or rashes)
Adults (including the elderly) and children over
10 years: Start with 1 tablet (25 mg) taken at night.
This may be increased to a maximum of 1 tablet
(25 mg) twice a day if necessary.
Children 5-10 years: A single tablet (25 mg) given
at night. DO NOT give more than 25 mg per day.
Children 2-5 years: A liquid form of this medicine
should be used.

For treatment and prevention of feeling sick
or being sick (such as travel sickness)
Adults (including the elderly) and children over
10 years: A single tablet (25 mg) taken the night
before the journey. This may be repeated after 6 to 8
hours if necessary.
Children 5-10 years: A liquid form of this medicine
or Promethazine 10 mg tablets should be used.
Children 2-5 years: A liquid form of this medicine
should be used.

As a short-term sedative (under the advice of
a doctor only)
Adults (including the elderly) and children over
10 years: 1 or 2 tablets (25 mg to 50 mg) taken at
night.
Children 5-10 years: A single tablet (25 mg) given
at night.
Children 2-5 years: A liquid form of this medicine
should be used.
Children under 2 years
DO NOT give this medicine to children under 2 years
old.

If you take more Promethazine than you
should
If you or your child accidentally takes too many tablets,
tell a doctor or go to a hospital casualty department
straight away. Take the medicine pack with you. This
is so the doctor knows what you or your child has
taken.
The following effects may occur:
In children: Feeling excited, moving unsteadily
or stumbling, uncontrolled movements especially
of the hands or feet, hearing or seeing things that
are not there (hallucinations), fits, loss of
consciousness, uneven heart beat and breathing
difficulties
In adults: Feeling drowsy or sleepy, fits, loss of
consciousness, uneven heart beat and breathing
difficulties.

If you forget to take Promethazine

unusual movements of the tongue, facial muscle
spasms, rolling eyes, trembling
over-active behaviour in children
very fast, uneven or forceful heart beat
(palpitations)
changes in the numbers and types of your blood
cells. If you notice increased bruising,
nosebleeds, sore throats, infections, excessive
tiredness, breathlessness or abnormal paleness
of the skin, you should tell your doctor who may
want you to have a blood test.
Tell your doctor or pharmacist if any of the
following side effects become serious or last
longer than a few days:
dry mouth, blurred vision, constipation and
difficulty in passing urine, especially in the
elderly and children
feeling drowsy, sleepy, dizzy or tired,
headaches, fits
feeling confused, especially in the elderly
feeling depressed, restless or disorientated (not
knowing where you are), having nightmares or
problems sleeping
loss of appetite, feeling or being sick, diarrhoea,
indigestion, stomach upsets
feeling dizzy, lightheaded or faint (hypotension)
skin rash, itching, red and raised lumps (hives)
being more sensitive to the sun than usual. If
this happens keep out of direct sunlight and do
not use sunbeds.
Also tell your doctor or pharmacist if you notice
any side effects not listed in this leaflet.

5. HOW TO STORE PROMETHAZINE
Keep out of the reach and sight of children.
Store below 25°C and protect from light. Store in
the original package or container and keep the
container tightly closed.
Do not use the tablets after the expiry date, which is
stated on the package or container. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What Promethazine tablets contain
The active substance (the ingredient that makes the
tablets work) is promethazine hydrochloride.

Do not take a double dose to make up for a forgotten
dose.
If you are taking Promethazine for an allergic
condition - take your medicine as soon as you
remember, then carry on as before
If you are taking Promethazine for sedation or
sleeping problems - miss that dose and take the
next evening's dose as usual.

The other ingredients in the tablets are lactose, maize
starch, pregelatinised maize starch, magnesium
stearate, talc, bleached shellac, titanium dioxide
(E171), povidone, sucrose, beeswax, carnauba wax
and opalux blue which contains patent blue (E131),
indigo carmine (E132), titanium dioxide (E171) and
sodium benzoate (E211).

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

What Promethazine tablets look like and
contents of the pack

4. POSSIBLE SIDE EFFECTS
Like all medicines, Promethazine can cause side
effects, although not everybody gets them.
STOP TAKING this medicine and see a doctor
or go to a hospital straight away if you notice
any of the following side effects:
an allergic reaction. The signs may include a
rash, swelling of the face, lips, tongue or throat,
difficulty in breathing or swallowing, sudden
wheezing or collapse

liver problems which may cause yellowing of
the skin or whites of the eyes (jaundice)
muscle stiffness or shaking
being unable to control some muscles in the
head or face

Promethazine tablets are blue, sugar-coated tablets
which come in blister packs of 10 and 30 tablets and
in containers of 100, 500 and 1000 tablets.

Marketing Authorisation Holder
Chelonia Healthcare Limited,
Boumpoulinas 11, 3rd Floor
Nicosia, P.C. 1060 Cyprus

Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9JQ
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last approved in January 2012
PMZ0092/0025S/LEA002

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
(web1)