Consumer medicine information

Vitamin A Capsules

Retinol

BRAND INFORMATION

Brand name

Vitamin A Capsules

Active ingredient

Retinol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Vitamin A Capsules.

What is in this leaflet

This leaflet answers some common questions about Vitamin A Capsules.

It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Vitamin A Capsules against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor.

Keep this leaflet in a safe place.

You may need to read it again.

What Vitamin A Capsules are used for

The high doses of vitamin A in Vitamin A Capsules are used for the treatment of symptoms associated with a severe deficiency of vitamin A in the diet. These symptoms include long term infections, skin rashes, acne, skin ulcers and eye problems.

Vitamin A Capsules are also used to relieve the symptoms of pre-menstrual tension and to prevent infections of the airways.

Vitamin A is also known as retinol.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor’s prescription.

There is not enough information to recommend the use of this medicine for children under 8 years of age.

Before you take Vitamin A Capsules

When you must not take it

You should not take Vitamin A Capsules if you have an allergy to:

  • any medicine containing vitamin A or retinol
  • any of the ingredients listed at the end of this leaflet
  • any other similar medicines.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not take this medicine if you have ingested too much vitamin A and have symptoms of an overdose of vitamin A.

Symptoms of an overdose are listed under the Overdose section below.

You should not take this medicine if you are pregnant.

It may affect your developing baby if you take it during pregnancy.

Do not breast-feed if you are being given this medicine.

It is not known if Vitamin A, the active ingredient in Vitamin A Capsules, passes into breast milk, so it is recommended that you avoid breast feeding after being given Vitamin A Capsules until your doctor says you can.

Do not give this medicine to children.

The safety and effectiveness of Vitamin A Capsules in children below 8 years of age have not been established.

Do not take this medicine after the expiry date printed on the pack, or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have, or have had any of the following medical conditions:

  • liver disease.

Tell your doctor if you are pregnant, plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

Vitamin A Capsules should not be administered to pregnant females.

If you have not told your doctor about any of the above, tell him/her before you start taking Vitamin A Capsules.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist.

Some medicines and Vitamin A Capsules may interfere with each other. These include:

  • any medicine containing vitamin A or retinol.

These medicines may be affected by Vitamin A Capsules or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with, or avoid, while taking this medicine.

How to take Vitamin A Capsules

How it is given

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.

How much to take

For adults and children over 8 years old with a severe deficiency the usual dose is 2 capsules daily for three days and then one capsule daily for 2 weeks.

Your doctor may adjust your dose depending on your response to the treatment and the severity of your condition.

How to take it

Swallow the capsules whole with a full glass of water.

When to take it

Take your medicine at about the same time each day.

Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

If you forget to take it

If it is less than 12 hours before your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

The symptoms of an overdose are the same as side effects but may be more severe.

Symptoms of an overdose may include:

  • severe headaches
  • dizziness
  • irritability
  • drowsiness
  • vomiting, nausea
  • blurred vision due to swelling of the nerves at the back of the eye
  • itchy, red or peeling skin.

In babies symptoms of an overdose may include:

  • vomiting
  • bulging of the soft spot on the top of a baby’s head (fontanelle).

If you think that you, or anyone else, may have taken too many Vitamin A Capsules or notice any symptoms of an overdose, immediately contact your doctor or go to the Emergency Department at the nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Contact the Poisons information centre on 13 11 26 for further advice on overdose management.

While you are using Vitamin A Capsules

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Vitamin A Capsules.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.

It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

It may interfere with the results of some tests.

Keep all of your doctor’s appointments so that your progress can be checked.

Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not take Vitamin A Capsules to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful when driving or operating machinery until you know how Vitamin A Capsules affect you.

This medicine may cause dizziness or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Things that would be helpful for vitamin A deficiency

Some self help measures suggested below may help your condition. Your doctor or pharmacist can give you more information about these measures.

Eat a well balanced and healthy diet with a mixture of colourful fruits and vegetables. Retinol is found in liver and whole milk.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Vitamin A Capsules.

This medicine helps most people with a lack of vitamin A but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical attention if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • vomiting, nausea
  • red, dry, itching, peeling skin, skin rash
  • fatigue
  • drowsiness and irresistible desire to sleep
  • dizziness
  • irritability
  • change in hair growth or loss of hair
  • cracked lips
  • bone pain
  • loss of appetite and weight loss
  • swelling of the hands, ankles or feet.

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to the Emergency Department at your nearest hospital:

  • severe headaches
  • swelling or tenderness in the stomach
  • blurred vision due to swelling of the nerves at the back of the eye
  • neurologic symptoms such as paralysis, difficulty speaking, walking or with vision, weakness and confusion.

In babies:

  • vomiting
  • bulging of the soft spot on the top of a baby’s head (fontanelle).

The above list includes some very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Some of these side effects for example, high calcium levels in the blood or changes in cholesterol levels can only be found when your doctor does tests from time to time to check your progress.

After using Vitamin A Capsules

Storage

Keep your capsules in the bottle until it is time to take them.

If you take the capsules out of the bottle they may not keep well.

Keep your capsules in a cool dry place where the temperature stays below 25°C. Protect from light.

Do not store Vitamin A Capsules or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Vitamin A Capsules are clear, orange, spherical, soft gelatin capsules packed in an amber glass bottle.

Each bottle contains 100 capsules.

Ingredients

Each Vitamin A Capsule contains 15,000 microgram retinol equivalents equal to 50,000 international units of vitamin A (retinol palmitate) as the active ingredient.

It also contains:

  • soya oil
  • allura red
  • caramel (class IV)
  • gelatine
  • glycerol
  • methyl hydroxybenzoate
  • propyl hydroxybenzoate
  • vanillin
  • water-purified
  • sodium chloride.

This medicine does not contain lactose, sucrose, tartrazine or gluten.

Supplier

Vitamin A Capsules are supplied in Australia by:

Phebra Pty Ltd
19 Orion Road
Lane Cove NSW 2066
Australia

Vitamin A Capsules
AUST R 13331
Phebra product code-TAB008

This leaflet was amended 9th May 2012.

BRAND INFORMATION

Brand name

Vitamin A Capsules

Active ingredient

Retinol

Schedule

S4

 

Name of the medicine

Retinol (vitamin A).

Excipients

Soya oil, allura red, caramel (class IV), gelatin, glycerol, methyl hydroxybenzoate, propyl hydroxybenzoate, vanillin and purified water. Vitamin A capsules also contain sodium chloride.

Description

Chemical name: the principal and biologically most active substance is all-(E)-retinol (all-(E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-enyl)nona-2,4,6,8-tetraen-1-ol; C20H30O). Vitamin A palmitate is an ester. Molecular formula: C36H60O2. MW: 524.86. CAS: 79-81-2.

Pharmacology

Pharmacodynamics.

Vitamin A is necessary for the growth and differentiation of epithelial cells. It is essential for vision, particularly in dim light due to its effect on the function of the retina and is needed for normal bone growth, embryonic development and reproduction. Different forms of vitamin A have activities in different tissues; retinol is the functional form in the eye while retinoic acid is the active form responsible for growth, differentiation and transformation functions.

Pharmacokinetics.

Absorption.

Vitamin A is readily absorbed from the gastrointestinal tract. The ester is hydrolysed in the intestine by pancreatic enzymes and uptake by intestinal cells occurs by a carrier mediated process. Absorption may be reduced in the presence of reduced hepatic or pancreatic function.

Distribution and metabolism.

After absorption, retinol is re-esterified and taken up by the liver until hepatic stores are saturated. It is then hydrolysed and released from the liver, 95% bound to retinol binding protein (RBP). Retinol bound to RBP binds to specific sites on the target cell surface where it is transferred to a membrane bound protein and converted to retinol ester. In the retina, retinol is converted to 11-cis-retinol and incorporated into rhodopsin. In other tissues, retinol appears to be oxidised to retinoic acid and conveyed to the nucleus as a complex.

Excretion.

Retinol is excreted by formation of glucurononide conjugates and subsequent oxidation to retinol and retinoic acid, which is excreted with other metabolites in the urine and faeces.

Indications

Vitamin A capsules are indicated for the oral treatment of: chronic infections; dermatitis; acne, skin ulcers and eye lesions when due to vitamin A deficiency; premenstrual tension; for prophylaxis against respiratory infections.

Contraindications

Vitamin A is contraindicated in hypervitaminosis A or when there is sensitivity to any of the ingredients of this preparation.

Precautions

Vitamin A must be protected from light.

Use in pregnancy.

(Category D)
Vitamin A capsules should not be administered to pregnant females.
Preparations with a daily dose of greater than 1,500 microgram retinol equivalents (RE) should be avoided because of the teratogenic effects of large doses of vitamin A. The recommended adult daily requirement for vitamin A from all sources is 750 microgram RE. This is usually provided in the diet. Taking more than 750 microgram RE a day as a supplement during pregnancy may cause birth defects.

Adverse Effects

Adverse effects and overdosage.

Acute toxicity.

This may occur after very high doses are administered and may produce the following symptoms.
Drowsiness and irresistible desire to sleep, dizziness, irritability, severe headache due to increased intracranial pressure, hepatomegaly, vomiting, nausea, papilloedema, and erythema, pruritus and peeling of skin.
The typical symptoms of acute toxicity in infants are bulging of the fontanelle and vomiting.

Chronic toxicity.

Chronic toxicity is characterised by dry and itching skin, peeling skin, erythematous dermatitis and disturbed hair growth. Cracked lips, bone pain, hyperostosis, papilloedema, loss of appetite and weight loss, fatigue, irritability, oedema, headaches and haemorrhages may occur. Neurological symptoms similar to those of a brain tumour may also occur due to increased intracranial pressure.
Increased intracranial pressure, possibly with bulging of the fontanelle and vomiting are often seen as an early symptom in infants.
Pathological changes in the liver including hypertrophy of fat storing cells, fibrosis, sclerosis of central veins and cirrhosis leading to portal hypertension and ascites may occur. Alkaline phosphatase activity may also be increased due to increased osteoblastic activity. Increases in plasma triglyceride and falls in HDL cholesterol may also occur. Hepatosplenomegaly has been reported as well as premature closure of epiphyses and hypercalcaemia in children.

Dosage and Administration

Adults and children over 8 years.

Severe deficiency: 2 capsules daily for three days then 1 capsule daily for two weeks.
Poor dietary habits should be corrected and an abundant and well balanced diet directed.

Overdosage

Treatment of toxicity includes cessation of vitamin A administration and supportive therapy.
In Australia, contact the Poisons Information Centre on 131 126 for further advice on overdose management.

Presentation

Capsules, 15,000 microgram retinol equivalents ≡ 50,000 IU vitamin A: 100's (bottle, AUST R 13331).

Storage

Store below 25°C. Protect from light.

Poison Schedule

S4.