Patient Information Leaflet

ARMILLA 400 I.U. Soft Capsules

Vitamin E (RRR-α-Tocopherol)
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

Keep this leaflet. You may need to read it again.
If you would like further information or advice, please consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement, or if you notice a worsening of symptoms.

Contents of this leaflet:

What ARMILLA is and what it is used for
What you need to know before taking ARMILLA
How to take ARMILLA
Possible side effects
How to store ARMILLA
Package contents and other information

1. What ARMILLA is and what it is used for

ARMILLA contains vitamin E.
ARMILLA is indicated:

in conditions characterized by vitamin E deficiency caused by inadequate absorption of nutrients from food during digestion;
in conditions where prevention of excessive free radical production is required.

2. What you need to know before taking ARMILLA

Do not take ARMILLA

if you are allergic to vitamin E or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking ARMILLA.
In particular, inform your doctor if:

you are already being treated with digitalis (a medicine used to treat heart conditions) or insulin (a medicine used to treat diabetes). In such cases, your doctor may carry out blood tests (see section 2 “Other medicines and ARMILLA”);
you have vitamin K deficiency (vitamin K is involved in the blood clotting process). If you take doses of vitamin E exceeding 800 mg per day (equal to 800 IU) for a prolonged period, you may be at increased risk of bleeding. Therapeutic use of tocopherol is associated with an increased risk of lack of blood flow to the brain caused by bleeding (hemorrhagic stroke).

Other medicines and ARMILLA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
In particular, inform your doctor if you are taking:

warfarin, anticoagulants, thrombolytics, or platelet aggregation or hemostasis inhibitors, which are medicines that make the blood less likely to clot. Vitamin E may increase the risk of bleeding.
digitalis, a medicine used to treat heart conditions
insulin, a medicine used to treat diabetes, as vitamin E may enhance the effect of these drugs.
Vitamin A
Vitamin K (involved in blood clotting processes), as high-dose vitamin E intake may reduce the absorption of these vitamins.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
Take ARMILLA only if clearly needed and only after your doctor has carefully evaluated your condition and adjusted the dosage based on your blood test results. Your doctor will also carry out regular monitoring during treatment.
Driving and using machines
ARMILLA has no effect on the ability to drive or operate machinery.
ARMILLA contains soybean oil
This medicine contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take ARMILLA

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 400 mg (1 capsule) daily (equivalent to 400 I.U.).

If you take more ARMILLA than you should
If you accidentally ingest/overdose on ARMILLA, contact your doctor immediately or go to the nearest hospital.

Symptoms
You may experience the following symptoms: nausea, diarrhoea, fatigue, muscle weakness.
If you take daily doses exceeding 1 g, you may experience transient disturbances such as nausea, diarrhoea, and intestinal gas. Other symptoms you may experience include: fatigue, feeling of weakness, headache, blurred vision, and skin inflammation.

Treatment
Stop treatment with ARMILLA and contact your doctor immediately or go to the nearest hospital. Your doctor will provide appropriate treatment, if necessary.
It is not known that ingestion/overdose of ARMILLA may cause chronic adverse effects.

If you forget to take ARMILLA
Do not take a double dose to make up for the forgotten dose.

If you stop taking ARMILLA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, stop taking the medicine and inform your doctor:

allergic reactions, even severe ones, whose symptoms may include hives, swelling due to allergy, difficulty breathing, skin redness, skin rash and blisters.

The side effects reported with vitamin E use are as follows:
Effects related to the mouth, stomach and intestine:
diarrhoea, stomach and abdominal pain, nausea, passing wind
Effects related to the skin:
skin rash, itching
Effects related to the whole body:
tiredness (after taking high doses)
Effects related to muscles and bones:
muscle weakness (after taking high doses)

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ARMILLA

This medicinal product does not require any special storage conditions.
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 after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ARMILLA contains

The active substance is RRR-α-Tocopherol, oily solution 400 mg (equivalent to 400 IU of vitamin E).
The other components are refined soybean oil (see section 2, “ARMILLA contains soybean oil”), gelatin, glycerol.

Description of the appearance of ARMILLA and contents of the pack
ARMILLA is presented as a soft gelatin capsule.
It is available in packs of 30 capsules of 400 IU.
Marketing Authorization Holder
ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa
Sales License Holder:
OMIKRON ITALIA Srl
Viale B. Buozzi, 5
00197 – Roma
Manufacturer
CATALENT ITALY S.p.A.
Via Nettunense Km 20+100
04011 Aprilia (LT)
ABIOGEN PHARMA S.p.A.
Via Meucci, 36 – Ospedaletto – Pisa