Mac Majesta

Composition:

Each enteric coated tablet contains:
Pyridoxine Hydrochloride BP……….10 mg
Doxylamine Succinate USP…………..10 mg

Pharmaceutical Form: Tablets

Read all of this leaflet carefully before you start taking MAC MAJESTA.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, please ask your doctor or pharmacist.
– This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.What MAC MAJESTA is and what it is used for
2. What you need to know Before you take MAC MAJESTA
3. How to take MAC MAJESTA
4. Possible side effects
5. How to store MAC MAJESTA
6. Further information

1. What MAC MAJESTA is and what it is used for
What MAC MAJESTA is
MAC MAJESTA contains two medicines (‘active substances’) called: ‘doxylamine succinate’ and ‘pyridoxine hydrochloride’.

Doxylamine succinate belongs to a group of medicines called ‘antihistamines.
Pyridoxine hydrochloride is another name for Vitamin B6.

What MAC MAJESTA is used for
MAC MAJESTA is used in pregnant women, to help stop them feeling sick (nausea) and being sick (vomiting). It is used when changes in diet or other non-medicine treatments have not worked.

2. What you need to know before you take MAC MAJESTA Do not take MAC MAJESTA if:

you are allergic to doxylamine succinate or other antihistamines (such as diphenhydramine), pyridoxine hydrochloride.
you are taking medicines for depression called ‘monoamine oxidase inhibitors’ (MAOIs)

Do not take MAC MAJESTA if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before taking MAC MAJESTA.

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking MAC MAJESTA if you have ever had:

asthma
increased eye pressure
an eye problem called ‘narrow angle glaucoma’
a stomach ulcer
a blockage in your gut, between your stomach and small intestine
a blockage in your

Also, talk to your doctor or pharmacist or nurse before taking MAC MAJESTA if:

you are taking cough or cold medicines, sleeping medicines or certain pain medicines
you have been drinking

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking MAC MAJESTA.

If you suffer from severe nausea and vomiting of pregnancy, a condition called hyperemesis gravidarum, you have to be treated by a specialist.

If you are having a urine drug screen, taking MAC MAJESTA may show ‘false positive’ results for methadone, opiates, and phencyclidine phosphate (PCP) when some test methods are used. If this happens, a more specific test can be performed.

Look out for side effects

MAC MAJESTA may make you feel sleepy – do not drive, cycle or use any tools or machines while taking this medicine. Also, do not do other things that need your full attention – unless your doctor tells you it is okay to do so.
Do not take MAC MAJESTA while taking cough and cold medicines, sleeping medicines, certain pain medicines or if you have been drinking Taking MAC MAJESTA with other medicines that affect the ‘central nervous system’ can make you feel very sleepy – this can make you fall over or cause other accidents.

Do not stop taking MAC MAJESTA without talking to your doctor first. If you stop taking this medicine suddenly your feeling sick (nausea) and being sick (vomiting) may come back. Your doctor will tell you how to stop taking this medicine slowly over time to help avoid this.

Children and young people
MAC MAJESTA is not meant for use in children under 18 years old. It is not known if MAC MAJESTA is safe and effective in this age group.

Vitamin B
Talk to your doctor, pharmacist or nurse before taking any additional vitamin B – this could be through your diet, from supplements or multi-vitamins.

Other medicines and MAC MAJESTA
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal medicines.

In particular, do not take MAC MAJESTA and tell your doctor or pharmacist or nurse if you are taking any of the following:

Medicines for depression called ‘monoamine oxidase inhibitors’ (MAOIs) – using these medicines with MAC MAJESTA can make side effects worse and last
Medicines such as cough and cold medicines, sleeping medicines or certain pain medicines (called central nervous system depressants) – using any of these with MAC MAJESTA can make you feel very This can make you fall over or cause other accidents.

MAC MAJESTA with alcohol
Do not drink alcohol while taking MAC MAJESTA. See section 3 for information about how to take MAC MAJESTA.
Pregnancy and breast-feeding
MAC MAJESTA is for use in pregnant women.

If you are breastfeeding, a decision should be made with your doctor whether to discontinue breast- feeding or to discontinue the drug. This is because MAC MAJESTA can pass into your breast milk and may harm your baby.

Driving and using machines
Do not drive, cycle or use any tools or machines while taking this medicine. This is because you may feel sleepy after taking MAC MAJESTA. If this happens do not do other activities that need your full attention unless your doctor tells you it is ok to do so.

3. How to take MAC MAJESTA

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
How much to take
Your doctor will start you on a low dose and possibly increase it – this will depend on how well the medicine works for you.

How to start taking MAC MAJESTA and increase your dose, if needed:
. Day 1

Take 2 tablets, by mouth at

. Day 2

Take 2 tablets, by mouth at
If your nausea and vomiting is better or controlled on Day 2, continue to take 2 tablets every night at bedtime. This will be your usual dose unless your doctor, pharmacist or nurse tells you otherwise.

. Day 3

If you still had nausea and vomiting on Day 2, take 3 tablets, by mouth on Day 3 (1 tablet in the morning and 2 tablets at bedtime).

. Day 4

If your nausea and vomiting was better or controlled on Day 3 continue to take 3 tablets each day (1 tablet in the morning and 2 tablets at bedtime). This will be your usual dose unless your doctor, pharmacist or nurse tells you otherwise.
If you still had nausea and vomiting on Day 3, take 4 tablets, by mouth each day (1 tablet in the morning, 1 tablet in the mid-afternoon, and 2 tablets at bedtime).

Do not take more than 4 tablets each day (1 in the morning, 1 in the mid-afternoon, and 2 at bedtime).

Taking this medicine

Take MAC MAJESTA on an empty
Swallow the tablet whole with a glass of
Do not crush, chew, or split the tablets before

If you cannot swallow MAC MAJESTA tablets whole, tell your doctor, pharmacist or nurse.

If you take more MAC MAJESTA than you should
If you take more MAC MAJESTA than you should, stop taking MAC MAJESTA and talk to a doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: feeling restless, sleepy or dizzy, dry mouth, larger black part of the eye (dilated pupils), confusion, fast heart rate.
If the amount of medicine in your body is very high, you may also have fits, muscle pain or weakness or sudden severe kidney problems. These may even lead to death. If you have these signs – stop taking MAC MAJESTA and talk to a doctor or go to a hospital straight away.
If you stop taking MAC MAJESTA
Do not stop taking MAC MAJESTA without talking to your doctor first. If you stop taking this medicine suddenly your feeling sick (nausea) and being sick (vomiting) may come back. Your doctor will tell you how to stop taking this medicine slowly over time to help avoid this.

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

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

Very common: may affect more than 1 in 10 people

feeling very

Common: may affect up to 1 in 10 people

feeling dizzy
feeling tired
dry

Not known: frequency cannot be estimated from the available data

hypersensitivity (allergic reaction)
feeling anxious, difficulty in sleeping (insomnia), nightmares, feeling disorientated
headaches or migraines
tingling, pricking or numbness of skin
restlessness and a need to move constantly
problems with eyesight or blurred vision
sensation of spinning dizziness
difficulty breathing, awareness of heartbeat or increased heart rate
full or bloated feeling, stomach pains, constipation or diarrhoea
excessive sweating, skin reactions such as itchiness or rash
difficulties or pain with passing urine
discomfort in the chest
general discomfort or feeling irritable

Other side effects reported with medicines in the same drug class as doxylamine
Anticholinergic effects include (blockage of the activity of organs that receive nerve impulses through a substance called acetylcholine): dry mouth, nose and throat; difficulties or pain with passing urine; sensation of spinning dizziness; problems with eyesight or blurred vision; double vision (diplopia); ringing or humming in the ears (tinnitus); inflammation of the inner ear which develops within a short time (acute labyrinthitis); difficulty in sleeping (insomnia); shaking (tremors) and nervousness; feeling irritable; involuntary repetitive movements of the face (facial dyskinesia). In addition, feeling of tightness in the chest, thick mucus in the chest (bronchial secretions); high-pitched whistling sound often associated with difficulty in breathing (wheezing); stuffy nose; sweating and feeling chills; early menses; altered state of mind such as hallucinations, delusions, confusion and disturbed thoughts (toxic psychosis); headaches; tingling, pricking or numbness of skin; or feeling faint have been reported.

Rarely, low levels of white blood cells (agranulocytosis), reduced blood in the body due to increased destruction of blood cells (haemolytic anaemia), decreased clotting blood cells (thrombocytopenia),

decreased red, white and clotting cells in the blood (pancytopenia), and increased appetite, sometimes with weight gain, have been reported.

5. How to store MAC MAJESTA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 MAC MAJESTA contains

The active substances are doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6). Each tablet contains 10 mg of doxylamine succinate and 10 mg of pyridoxine

Presentation
MAC MAJESTA is available in blister packs containing 30