Pyridoxin, Vitamin B6 Tablets, 40mg pyridoxine hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
- 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. 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.
What is in this leaflet:
1. What Pyridoxin is and what it is used for
2. Before you take Pyridoxin
3. How to take Pyridoxin
4. Possible side effects
5. How to store Pyridoxin
6. Further information
1. What Pyridoxin is and what is used for
The active ingredient in Pyridoxin is pyridoxine hydrochloride, which is Vitamin B6.
It is used to treat low levels of Vitamin B6 in the body and in the treatment of a condition called idiopathic sideroblastic anaemia where the red cells in the blood do not form properly.
Pyridoxin can also be used to treat damage to the nerves (peripheral neuritis) caused by isoniazid, a drug used to treat tuberculosis.
2. Before you take Pyridoxin
Do not take Pyridoxin if:
- you are allergic to pyridoxine hydrochloride or any of the other ingredients of Pyridoxin (see section 6:‘Further Information’)
If the above statement applies to you, you should not take Pyridoxin
Talk to your doctor before taking Pyridoxin if:
- the patient is a child. Pyridoxin tablets are not recommended for children.
Taking other medicines
Taking another medicine while you are taking Pyridoxin can affect how it or the other medicine works. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those you may have bought yourself without a prescription.
Please check with your doctor if you are taking any of the following (or any other medication):
- levodopa, a drug used in the treatment of Parkinson’s disease
- isoniazid, used to treat tuberculosis
- oral contraceptives
- penicillamine, used to treat arthritis and other conditions.
If you have any doubts about whether you should take this medicine then discuss matters with your doctor before taking it.
Pregnancy and breast-feeding
You should let your doctor know if you are pregnant or wish to become pregnant, or wish to breast-feed, whilst taking these.
Driving and operating machines
Pyridoxin does not affect the ability to drive or operate machinery.
Important information on some ingredients in Pyridoxin
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.
3. How to take Pyridoxin
Your doctor will decide the dose which is best for you. Always follow your doctor’s or pharmacist instructions completely. Contact your doctor if your symptoms worsen or do not improve. If you do not understand, or are in any doubt, ask your doctor or pharmacist.
Unless instructed differently, take your tablets with a glass of water.
Adults and Children over 12
Deficiency states: 20-50mg up to three times daily.
Isoniazid neuropathy:
Prophylaxis: 10mg daily.
Therapeutic: 50mg three times daily.
Idiopathic sideroblastic anaemia: 100mg-400mg daily in divided doses.
Elderly
As for adults, no information to suggest that reduced dosage requirements are necessary.
Children under 12 years
Little information is available on the use of pyridoxine in children. Doses of 4mg/kg have been used to treat children with familial pyridoxine resistance.
If you take more Pyridoxin than you should
If you accidentally take too many tablets contact your doctor or pharmacist or nearest hospital casualty department. Take this leaflet and any remaining tablets with you to show the doctor or pharmacist.
If you miss a dose of Pyridoxin
If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Do not take a double dose to make up for a forgotten tablet.
Stopping Pyridoxin Tablets
You should continue to take Pyridoxin tablets for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like many medicines Pyridoxin may cause side effects in some patients, although not everybody gets them.
If you take large doses of Pyridoxin for a long time you may develop problems with your nerves (peripheral neuritis). One of the symptoms of peripheral neuritis can be pins and needles.
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.
To report any side effect(s):
The National Pharmacovigilance and Drug Safety Center (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222
Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States: Please contact the relevant competent authority
5. How to store Pyridoxin
- Keep out of the reach and sight of children.
- Do not use Pyridoxin after the expiry date which is stated on the carton and the blister.
- Store below 30°C, in a dry place.
- Do not use Pyridoxin if you notice any visible sign of deterioration.
- Medicines shouldnot 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 Pyridoxin contains
Active ingredient is pyridoxine hydrochloride. Each tablet contains 40mg of pyridoxine hydrochloride.
Excipients: Aerosil 200, lactose, microcrystalline cellulose, cellulose powder, talc, and magnesium stearate
What are the available packs of Pyridoxin
Pyridoxin tablets are available in packs of 20 tablets, 200 tablets and hospital packs of 1000 tablets.
Marketing Authorization Holder and Manufacturer
Alpha Pharma
King Abdullah Economic City, Rabigh. Saudi Arabia
Email: regulatory@alphapharma.com.sa
Tel: +966 12 21 29013
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