RETINOL AND COLECALCIFEROL 4500 IU/450 IU CAPSULES SOFT - patient leaflet, side effects, dosage

Base Label 150 × 38mm

® TOR GENERICS_

Page 3 – 140 × 38mm

What is in this leaflet

• 1. What Retinol and Colecalciferol 4500 IU/450 IU

Capsules are and what they are used for

• 2. What you need to know before you take Retinol and Colecalciferol 4500 IU/450 IU Capsules

• 3. How to take Retinol and Colecalciferol 4500 IU/450 IU Capsules

• 4. Possible side effects

• 5. How to store Retinol and Colecalciferol 4500 IU/450

IU Capsules

6. Contents ofthe pack and other information

1. What Retliol aid Colecalclferol 4500 IU/450 IU

Capsules are aid what they are used for

Retinol and Colecalciferol 4500 IU/450 IU Capsules contain the active ingredients Vitamin A or retinol palmitate (2645 micrograms of retinol palmitate are equivalent to 4500 IU Vitamin A) and Vitamin D3 or colecalciferol (11 micrograms ofcolecalcife­rol are

-...... -: ■ ■ ■ ■ ' ■

Page 10 – 140 × 38mm

The capsule should be swallowed whole with water, preferably with the main meal ofthe day.

The recommended dose in adults is one capsule per day but may be increased to 2 capsules per day following a blood test.

Use in childrenand adolescents

The recommended dose is one capsule per day but bmlay be increased to 2 capsules per day following a ood test.This medicine is not suitable for children under 6 years of age.

If you take more Retinoland Colecalciferol4500I­U/450 IU Capsules than you should

Ifyou accidentally take too many capsules tell your doctor or get other medical advice immediately. If possible, take the capsules, the box and this leaflet with you to show the doctor. If you take too many capsules you may experience drowsiness, feel irritable, feel or be sick, become constipated or have stomach pains, weak muscles, tiredness, lack of appetite, kidney problems and in severe cases irregular heartbeats.

Excpen s: Refined sunflower oi, ai-raa:-fiTocopheao, Geatni Gyceeo Purfied waee.Each papsueprpivdei: 2645 mppograr

retioi paiiiate (equivaaen o 4|i'j U viaaiin A aad 11 mrogars coeraKifeol (equvaient 'O 450 U vita­arin D3)

EU.ipei!S: Reiliejsu iiowee oi, al-ra.-mocopieeo,iGeatn g ponoiiioj Gyceo, Purfied watte. Each papsueprpivde: 2645 mcroaams retnoi pamitae (equivaaent © 4500 U vtamni a) and 11 * mizroaam poeiaKifeol (equoaent ti 450 U vitamin D3

n ColecsIclferol 4500 IU/450 IU Capsule, soft

Tor Gerercs Ltd; Northwood HA6 2lH, UK

Leaflet sits here

Page 4 – 140 × 38mm

Page 5 – 140 × 38mm

Page 6 – 140 × 38mm

Page 7 – 140 × 38mm

Page 8 – 140 × 38mm

Vitamin A is found in the diet. Vitamin A helps your immune system to work against infections, helps vision and helps to keep your skin and linings of some body parts, such as the nose, healthy.

Vitamin D is found in the diet and is also produced in the skin after exposure to the sun. Often vitamin D is given in combination with calcium. Vitamin D helps to regulate the amount of calcium and phosphate in the body; these are needed to keep bones and teeth healthy.

Your doctor of pharmacist may give you Vitamins A and D to prevent vitamin A and D deficiencies. Certain medical conditions may increase the risk of deficiency ofvitamins A and D.

2. What you ieed to kiow before you take Retliol aid Colecalclferol 4500 IU/450 IU Capsules

Do not takeVitamins A and D if:

– You are allergic (hypersensitive) to vitamin A and/or D or any ofthe other ingredients in the capsules (these

are listed in section 6, Further information)

• – Have high levels of vitamin A and/or D in your blood (hypervitaminosis A and/or D)

• – Have high blood levels of calcium (hypercalcaemia) or high urine levels of calcium (hypercalciuria)

• – Have kidney stones or serious kidney problems

This medicinal product contains traces of soya bean lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

Warnings and precautions

Talkto your doctor before taking Vitamins A and D if:

• – You have kidney damage or disease. Your doctor will need to measure the levels of calcium in your blood or urine

• – You suffer from liver disease

• – You are being treated for heart disease

• – You have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes)

• – You have osteoporosis and you are already taking

additional doses of calcium or vitamin D. Whilst you are taking colecalciferol your doctor will monitor your blood levels ofcalcium to make sure they are not too high.

Children and adolescents

Retinol and Colecalciferol 4500 IU/450 IU Capsules are not suitable for children under 6 years.

Other medicines and Retinol and Colecalciferol

4500 IU/ 450 IU Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular the following medicines may interact with Vitamin A and D3:

– Contraceptive pills increase the level of vitamin A in

your blood.

– Heart medicines (cardiac glycosides such as digoxin). Your doctor may monitor your heart with an

electrocardiogram (ECG) and measure the levels of calcium in your blood.

Antiplatelet drugs, such as aspirin, and Vitamin E, the effects of antiplatelet drugs may be increased resulting in longer bleeding time.

Medicines with an anticoagulant effect (such as abciximab, clopidogrel, heparin, warfarin) may result in longer bleeding time.

Medicines to treat epilepsy (such as phenytoin) or medicines to make you sleep (barbiturates such as phenobarbitone) as these medicines can decrease the effect of vitamin D.

pills) and vitamin D can

increase the levels of calcium in your blood and may result in high blood levels of calcium

(hypercalcaemia).

– Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These can decrease

the effect of vitamin D.

– Laxatives (such as paraffin oil) or a cholesterol lowering drug called colestyramine may reduce the absorption ofvitamins A and D.

Actinomycin (a medicine used to treat some forms of cancer), drugs to treat HIV/AIDS (such as efavirenz and zidovudine) and imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases) as they may interfere with the metabolism of vitamin D.

Medicines that can cause pseudotumor cerebri (a condition in which the pressure around the brain increases causing headaches and vision problems),

including certain tetracycline antibiotics, as the pseudotumor cerebri symptoms may increase.

• – Excessive alcohol consumption increases the risk of liver damage due to Vitamin A

• – Retinoids, including bexarotene

Taking Retinol and Colecalciferol 4500 IU/450 IU

Capsules with food and drink

You can take Vitamins A and D3 with or without food and drink.

Page 11 – 140 × 38mm

Page 12 – 140 × 38mm

Page 13 – 140 × 38mm

Page 14 – 140 × 38mm

Ifyou forget to take Retinoland Colecalciferol 4500

IU/ 450 IU Capsules

If you forget to take your capsules, take them as soon as you can. Do not take a double dose to make up for a forgotten dose. After that, take the next capsule in accordance with the instructions given to you by your doctor.

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

4. Posslble slde effects

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

Side effects with Vitamin A at the recommended dose are rare, however, the frequency could not be determined from the available data.

Vitamin A toxicity has been reported in children. Children may be irritable, be sick and lose appetite.

Side effects with Vitamin D3 may include:

Uncommon sideeffects (affecting less than 1 in 100 people)

• – too much calcium in your blood (hypercalcaemia). You may feel or be sick, lose your appetite, have constipation, stomach ache, feel very thirsty, have muscle weakness, drowsiness or confusion

• – too much calcium in your urine (hypercalciuria).

– skin rash

– itching

– hives

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:.

By reporting side effects you can help provide more information on the safety ofthis medicine.

the last day of that month.

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. Coiteits of the pack aid other liformatloi

What Retinol and Colecalciferol 4500 IU/450 IU Capsules contain

The active substances are retinol palmitate or Vitamin A and colecalciferol orVitamin D3

The other ingredient in the capsule are refined sunflower oil, all-rac-a-tocopherol; the capsule shell contains gelatin, glycerol, purified water.

Free from: Gluten, nuts, starch, sugar, yeast and arachis oil

Retinol and Colecalciferol 4500 IU/450 IU Capsules are available in PP pots containing 84 capsules.

Marketing Authorisation Holder

TOR Generics Ltd, Northwood, HA6 2TH UK

Manufacturer

Central Pharma Contract Packing Ltd., Caxton Road, Bedford, MK41 OXZ, UK

This leaflet was last revised in April2019.

Page 1 (front) – 140 × 38mm

ERICS

lot Gererics Ld; l_U Northwood HA6 2TH UK

Retliol aid Colecalclferol 4500 l /450 IU Capsule, soft

nts Refined sunflower oil ai-rac-a-Tocophero, Geatn,

,'Purified water. Eachcapsule prpivdeS: 2645mirrogrars o pamitate (equwaie-t ■o 4500 U vitimin A) and 11 rrogrCTs coeraciferoi (equvvae*t to 450 U vitamin D3)