Patient leaflet - Adaflex Ava 5 mg tablets

1. What adaflex ava is and what it is used for

The active substance of adaflex ava, melatonin, belongs to a group of natural hormones produced by the body. The hormone helps regulate the body’s day- and night rhythm.

adaflex ava is used for:

Insomnia in children and adolescents (6 to 17 years old) with attention deficit hyperactivity disorder (ADHD), where other healthy sleeping routines have not worked well enough.
Delayed sleep-wake phase disorder (DSWPD) (disruption of the body’s day and night rhythm) in children and adolescents (6 to 17 years old) and adults up to 25 years of age, where healthy sleeping routines have not worked well enough.
Short-term treatment of jet lag in adults. Jet lag refers to the symptoms caused by the time difference when travelling across several time zones.

2. What you need to know before you take adaflex ava

Do not take adaflex ava

If you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking adaflex ava:

If you have diabetes or impaired glucose tolerance, as this medicine may increase the level of glucose in your blood
If you have liver or kidney problems
If you have an autoimmune disease (where the body is ‘attacked’ by its own immune system)
If you have epilepsy since adaflex ava may increase seizure frequency in patients with epilepsy
If you smoke. Smoking may reduce the effect of adaflex ava. Your doctor may need to adjust your dose.
If you are a woman of childbearing potential. Contraceptives should be used during treatment with adaflex ava. This medicinal product may however be affected by certain contraceptives, see the section ‘Other medicines and adaflex ava’ for more information.

It is unclear if significantly older people are sensitive to melatonin.

Children and adolescents

Do not give this medicine to children with ADHD or DSWPD below 6 years as its safety and efficacy are unknown.

Do not give this medicine to children or adolescents under 18 years of age to treat jet lag as its safety and efficacy are unknown for this indication.

Other medicines and adaflex ava

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If adaflex ava is taken at the same time as the following medicines, it can affect the way that adaflex ava or the other medicine works:

Depression (e.g. fluvoxamine, citalopram)
Sleep disorder (e.g. zolpidem)
Epilepsy (carbamazepine, phenytoin)
Ulcers (cimetidine, omeprazole)
Skin disorders (psoralens)
Heart conditions (verapamil)
High blood pressure (e.g. nifedipine, beta-blockers)
Bacterial infections (ciprofloxacin and norfloxacin)
Tuberculosis (rifampicin)
Prevention and treatment of blood clots (e.g. warfarin)
Contraceptives containing ethinylestradiol and gestagen
Hormone replacement therapy due to menopause problems
Pain and inflammation (non-steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid and ibuprofen)
Caffeine

adaflex ava with alcohol

Do not drink alcohol in connection with taking adaflex ava, as it may reduce the effect of melatonin.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should not use adaflex ava.

Contraceptives for fertile women and young girls

Fertile women and young girls should use contraceptives when taking adaflex ava. Some contraceptives may increase melatonin levels in the body (see “Other medicines and adaflex ava”).

Pregnancy

adaflex ava is not recommended if you are pregnant. Melatonin crosses the placenta and there is insufficient information on the risk this may pose to the unborn child.

Breast-feeding

adaflex ava is not recommended if you are breast-feeding. Melatonin passes into human milk, and a risk to the breast-fed child cannot be excluded.

Driving and using machines

adaflex ava can make you feel drowsy. If this happens, you must not drive or operate machinery.

adaflex ava contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take adaflex ava

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Insomnia in children and adolescents with ADHD

Melatonin treatment is prescribed by your doctor because other treatable causes of the sleep disorder have been ruled out and other sleep-promoting measures have been insufficient.

Recommended starting dose is 0.5 mg to 2 mg, taken 30-60 minutes before bedtime. The dose will be adjusted individually to a maximum of 5 mg per day, regardless of age. The lowest dose possible will be given.

Treatment should be followed up regularly by a doctor (at least every 6 months is recommended) to see if it is still appropriate. Treatment should be interrupted once a year to see if treatment is still needed.

Delayed sleep-wake phase disorder in children and adolescents aged 6-17 years, and adults up to 25 years of age

The standard recommended starting dose is 1 to 2 mg, taken 1-2 hours before bedtime. However, a starting dose of 0.5 mg may be sufficient. The dose may be adjusted gradually to a maximum of 5 mg per day, regardless of age. The lowest dose possible will be given.

Treatment should be followed up regularly by a doctor to see if it is still appropriate. For some patients, treatment can be continued past the usual age ranges if it is considered appropriate.

Adults with jet lag

The standard starting dose is 3 mg daily for a maximum of 5 days. The dose can be gradually adjusted within the range of 0.5 mg to 5 mg per day to alleviate your symptom. The lowest dose that alleviates your symptom should be used for the shortest time. Maximum treatment time is 5 days.

The first dose should be taken on arrival at destination at your usual bedtime. Intake on the following days should also be at your usual bedtime. The tablets should not be taken before 20:00 hr or after 04:00 hr.

adaflex ava may be taken for a maximum of 16 treatment periods per year.

Diabetes

If you have or your child has diabetes or impaired glucose tolerance, food should not be consumed 2 h before or after intake of adaflex ava, see Warnings and precautions.

How to take the medicine

adaflex ava should be swallowed. If needed, the tablet can be crushed and dispersed in water before intake.

Food should not be consumed 2 h before or after intake of adaflex ava.

If you take more adaflex ava than you should

If you or your child has accidentally taken too much medicine or if for example a child has ingested the medicine by mistake, contact a doctor, hospital, or pharmacist as soon as possible.

Taking more than the recommended daily dose may give you symptoms such as drowsiness, headache, dizziness and nausea.

If you forget to take adaflex ava

If you forget to take a dose at bedtime and wake during the night you may take the forgotten dose but at no later than 04:00 hr.

Do not take a double dose to make up for a forgotten dose.

If you stop taking adaflex ava

There are no known harmful effects if treatment is interrupted or ended. The use of adaflex ava is not known to cause any withdrawal effects after treatment completion.

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

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking adaflex ava and contact a doctor immediately:

Hypersensitivity reaction with symptoms such as swelling of face, swelling of mouth, swelling of tongue (Frequency not known: frequency cannot be established from the available data)
Chest pain (Rare side effects: may affect up to 1 in 1000 people)

Other side effects

If you experience any of the following side effects, contact a doctor and/or seek medical advice:

Common side effects: may affect up to 1 in 10 people

Headache
Sleepiness

Uncommon side effects: may affect up to 1 in 100 people

Irritability, nervousness, restlessness, anxiety
Insomnia, abnormal dreams, nightmares
Migraine, dizziness
Lethargy (tiredness) and lack of energy, restlessness associated with increased activity
High blood pressure
Abdominal pain, indigestion, mouth ulceration, dry mouth, nausea
Changes in the composition of your blood which can cause yellowing of the skin and eyes
Inflammation of the skin, itching, rash, dry skin, night sweats
Pain in arms and legs
Excretion of glucose in the urine, excess proteins in the urine
Menopausal symptoms
Feeling of weakness, chest pain
Abnormal liver function tests
Weight gain

Rare side effects: may affect up to 1 in 1000 people

Shingles
Reduced number of white blood cells in the blood
Reduced number of blood platelets
Low calcium or sodium levels in the blood
High level of blood fats
Altered mood, aggression, crying, stress symptoms, disorientation, early morning awakening, increased sex drive, depressed mood, depression
Fainting, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, ‘pins and needles’ feeling
Visual impairment, blurred vision, watery eyes
Vertigo (a feeling of dizziness or “spinning”), dizziness when standing or sitting
Feeling your heartbeat
Hot flushes
Acid reflux, gastrointestinal disorder, blistering in the mouth, tongue ulceration, stomach upset, vomiting, abnormal bowel sounds, wind, excess saliva production, bad breath, abdominal discomfort, stomach disorder, inflammation of the stomach lining
Eczema, skin rash, hand skin inflammation, itchy rash, psoriasis, nail disorder
Arthritis, muscle spasms, neck pain, night cramps
Passing large volumes of urine, urinating during the night, presence of red blood cells in the urine
Prolonged erection - that might be painful - without sexual stimulation, inflammation of the prostate gland
Tiredness, pain, thirst
Increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests

Frequency not known: frequency cannot be established from the available data

Abnormal milk secretion
Hallucinations (e.g. seeing, feeling or hearing things that don’t exist)
Drowsiness, sedation
High blood sugar

Reporting of side effects

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

Website: 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.

5. How to store adaflex ava

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 label after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.

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. Contents of the pack and other information

What adaflex ava contains

The active substance is melatonin 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg.
The other ingredients are microcrystalline cellulose (E 460), mannitol (E 421), silica colloidal anhydrous (E 551), croscarmellose sodium (E 468) and magnesium stearate (E 470b).

What adaflex ava looks like and contents of the pack

adaflex ava 0.5 mg is a white to almost white, round, biconvex tablet with ”0.5” marked on one side. Tablet size is 8 mm.

adaflex ava 1 mg is a white to almost white, round, biconvex tablet with ”1” marked on one side. Tablet size is 8 mm.

adaflex ava 2 mg is a white to almost white, round, biconvex tablet with ”2” marked on one side. Tablet size is 8 mm.

adaflex ava 3 mg is a white to almost white, round, biconvex tablet with ”3” marked on one side. Tablet size is 8 mm.

adaflex ava 4 mg is a white to almost white, round, biconvex tablet with ”4” marked on one side. Tablet size is 8 mm.

adaflex ava 5 mg is a white to almost white, round, biconvex tablet with ”5” marked on one side. Tablet size is 8 mm.

adaflex ava is available in plastic bottle packs, with either tamper proof caps or child-resistant and tamper proof caps. Pack sizes of 30 or 100 tablets per bottle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

AGB-Pharma AB

Scheeletorget 1, Medicon Village

223 81 Lund

Sweden

Manufacturer

Legosan AB

Viagatan 16

692 35 Kumla