AlfaD 0.25 microgram Capsule

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What AlfaD is and what it is used for
2. What do you need to know before you take AlfaD
3. How to take AlfaD
4. Possible side effects
5. How to store AlfaD
6. Contents of the pack and other information

• are allergic (hypersensitive) to alfacalcidol or any other vitamin D products, or to any of the other ingredients of this medicine (listed in section 6)
• have a peanut or soya allergy. These capsules contain small amounts of peanut oil (arachis oil), which can cause a severe allergic reaction in sensitive people
• have a condition called hypercalcaemia, which means you have high levels of calcium in your blood
• have a condition called calcification, which means you have high levels of calcium in your body tissues.

If you are unsure if any of the above apply to you, talk to your doctor before taking AlfaD.

Talk to your doctor, pharmacist, or nurse, before you start to take AlfaD if you:

• are taking any of the medicines in the “Other medicines and AlfaD” section below
• have kidney problems (including kidney stones)
• have a disease which leads to the formation of clumps of inflammatory cells in various organs (granulomas or sarcoidosis). You may be more sensitive to AlfaD.
• have an intolerance to some sugars as this medicine contains a small amount of sorbitol
• have a diet deficient in calcium, as AlfaD may not work as well.

You may get too much calcium or phosphate in your blood when you take this medicine. Please read Section 4 – Possible side effects - to enable you to spot any of the signs that this may be happening to you. You should notify your doctor, who may need to change your dose.

While you are taking AlfaD, your doctor will take regular blood tests. This is very important in children, patients with kidney problems, and patients on a high dose of AlfaD. This is to check the level of calcium and phosphate in your blood while you take your medicine. Depending on the results of these blood tests, your doctor may:

• prescribe another medicine called a phosphate binding agent to take as well as AlfaD. This will help to keep the right amount of phosphate in your blood.
• prescribe a calcium supplement, to take in addition to AlfaD, to ensure you have the correct amount of calcium in your blood.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take, any of the following medicines:

• cardiac glycosides (for heart problems) e.g. digoxin, as you may get too much calcium in your blood and this could result in an abnormal heart beat.
• barbiturates (to treat anxiety and insomnia) e.g. phenobarbital, as you may need a larger dose of AlfaD
• anticonvulsants (to control epilepsy or fits) e.g. phenytoin, carbamazepine, or primidone, as you may need a larger dose of AlfaD.
• mineral oil (to relieve constipation), as AlfaD may not enter your blood as usual.
• colestyramine or colestipol (used to lower cholesterol levels), as AlfaD may not enter your blood as usual.
• sucralfate (to treat and prevent ulcers), as AlfaD may not enter your blood as usual.
• large amounts of aluminium-containing antacids (to relieve heartburn and indigestion) e.g. aluminium hydroxide, as too much aluminium is toxic.
• magnesium-containing antacids (to relieve heartburn or indigestion) or laxatives (to treat constipation) e.g. magnesium hydroxide, as you may get too much magnesium in your blood.
• preparations containing calcium (for calcium deficiency) e.g. calcium gluconate, as you may get too much calcium in your blood.
• thiazide diuretics, often called “water tablets”, (for increasing the amount of urine you produce) e.g. bendroflumethiazide, as you may get too much calcium in your blood.
• any other preparations containing vitamin D (to treat bone disease), e.g. ergocalciferol, as you may get too much calcium in your blood.

Please tell your doctor or pharmacist if you are taking, have recently taken, or might take, any other medicines, including medicines obtained without a prescription.

• If you are pregnant, or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.

• AlfaD is not expected to affect your ability to drive or operate machinery. Check with your doctor if you experience any side effect from AlfaD that you feel may affect your ability to drive and/or use machinery (e.g., dizziness or decreased alertness).

• AlfaD capsules contain arachis oil (peanut oil). If you are allergic to peanut or soya, DO NOT take AlfaD.
• This medicinal product contains small amounts of ethanol (alcohol) (less than 2 mg per capsule). The amount of alcohol (ethanol) in one soft capsule of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine has no noticeable effects.
• AlfaD capsules contain a small amount (up to 3.16 mg per capsule) of sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you (or someone else) swallow a lot of the capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately.

An overdose is likely to cause loss of appetite, general weakness, feeling sick, being sick, weakness, sweating, diarrhoea, headache, weight loss, vertigo, thirst, and excessive urination.

Please take this leaflet, any remaining capsules, and the container with you to the hospital or doctor so that they know which capsules were consumed.

If you forget to take a capsule, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.

DO NOT stop taking your medicine without first talking to your doctor, pharmacist, or nurse , even if you feel better.

If the following happens, stop taking the capsules and tell your doctor immediately or go to the casualty department at your nearest hospital as you may be having a severe allergic reaction:

• swelling of the lips, face, or neck/throat
• severe difficulty in breathing due to swelling of the neck/throat
• a severe skin rash or hives.

This is a very rare, but very serious, side effect. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately if you notice any of the following as this could mean you have too much calcium or phosphate in your blood. These side effects may happen in up to 1 in 10 people:

• feeling or being sick
• general weakness and lack of energy
• loss of appetite
• feeling thirsty a lot
• Unexpected weight loss
• Sweating a lot
• experience vertigo (feel that you, or things around you, are moving when they are not)
• experience headaches
• needing to pass water (urine) a lot
• experience a dry mouth or a metallic taste in your mouth
• experience pain in your muscles or bones
• experience constipation or diarrhoea

Tell your doctor as soon as possible if you notice any of the following as this could mean you are developing problems with your kidneys, such as kidney stones forming. Kidney stones may cause a sharp spasm in one side of your lower back. The frequency of this side effect is unknown (it cannot be estimated from the data available):

• needing to pass water (urine) less often
• swelling of any parts of your body (oedema)
• fever with a pain in your side.

Other possible side effects for which the number of people affected in unknown (can not be estimated from available data):

• Urticaria (hives on your skin)

Other possible side effects, which may affect up to 1 in 10 people, include skin problems, such as:

• itching skin
• rash

Other possible side effects which may affect up to 1 in a 100 people include:

• Develop deposits of calcium in your kidneys (nephrocalcinosis) or other part of your body (ectopic calcification)

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

The active ingredient in AlfaD is alfacalcidol (1 α-hydroxyvitamin D₃) 0.25, 0.5 or 1 microgram. The other ingredients are:

• citric acid, anhydrous (E330)
• propyl gallate (E310)
• α-tocopherol (vitamin E) (E307)
• ethanol, anhydrous
• arachis oil (peanut oil)

The capsule shell contains:

• gelatin
• glycerol 85% (E422)
• Anidrisorb 85/70 (sorbitol, sorbitans, superior polyols and mannitol)

The printing ink contains:

• shellac 54% (E904)
• black iron oxide (E172)

The capsules contain the following colours:

• 0.25 microgram capsules: red iron oxide (E172)
• 0.5 microgram capsules: titanium dioxide (E171) and red iron oxide (E172)
• 1.0 microgram capsules: titanium dioxide (E171) and yellow iron oxide (E172).

• The 0.25 microgram capsules are oval, opaque, reddish-brown, elastic soft gelatin capsules containing a clear, pale-yellow, oily solution. They are printed ‘0.25’ on one side in black ink.
• The 0.5 microgram capsules are oval, opaque, pale pink, elastic soft gelatin capsules containing a clear, pale-yellow, oily solution. They are printed ‘0.5’ on one side in black ink.
• The 1 microgram capsules are oval, opaque, cream-to-ivory, elastic soft gelatin capsules containing a clear, pale-yellow, oily solution. They are printed ‘1.0’ on one side in black ink.

The product is available in pack sizes of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, or 168 capsules. Not all pack sizes may be marketed.

Marketing Authorisation holder:

Company responsible for manufacture:

AlfaD is a registered trademark of Theramex HQ UK Limited.