Novago

Package leaflet: Information for the patient

NOVAGO 50 mg tablets

Dimenhydrinate
Please read 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 told you to do.

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

Contents of this leaflet:

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

1. What NOVAGO is and what it is used for

This medicinal product contains the active substance dimenhydrinate, which belongs to a group of medicines called antihistamines.
NOVAGO is indicated for the treatment of symptoms such as vomiting, nausea, and dizziness when they occur following repetitive or irregular body movements, a condition also known as motion sickness, travel sickness, or seasickness (kinetosis).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking NOVAGO

Do not take NOVAGO

• if you are allergic to dimenhydrinate, to other antihistamine medicines, or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding;
• if the patient is a child under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking NOVAGO.
Take this medicine with caution:

• if you have high internal eye pressure (glaucoma);
• if you suffer from prostate disorders (prostatic hypertrophy) or other conditions characterized by incomplete bladder emptying (urinary retention);
• if you suffer from intestinal problems (intestinal obstruction);
• if you suffer from breathing problems (bronchial asthma);
• if you suffer from epilepsy;
• if you suffer from porphyria;
• if you suffer from arterial hypertension;
• if you suffer from cardiovascular diseases;
• if you suffer from chronic bronchitis or emphysema;
• if you suffer from hyperthyroidism.

This medicine may mask symptoms of ototoxicity and should therefore be administered with caution in patients receiving ototoxic drugs.
This medicine may worsen seizure disorders. It should therefore be used with great caution in patients with epilepsy.

Other medicines and NOVAGO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution if you are taking medicines used to treat sleep disorders or anxiety (barbiturates, hypnotics, sedatives, and tranquilizers), as NOVAGO may enhance their effects.
Take this medicine with caution if you are taking:

• anticholinergic medicines, used as antispasmodics;
• antidepressants, used to treat depression;
• aminoglycosides, medicines used to treat bacterial infections (antibiotics); in this case, NOVAGO may mask possible ear damage (ototoxicity) caused by aminoglycoside antibiotics.

NOVAGO and alcohol
Be cautious about consuming alcoholic beverages, as this medicine may increase the effects of alcohol.

Pregnancy and breastfeeding
Pregnancy
Reproduction studies in rats and rabbits using doses 20–25 times higher than those normally used in human therapy did not show teratogenic effects or reduced fertility. However, data on the use of this product in pregnant women are not available. Therefore, although teratogenicity of the product appears unlikely, the use of dimenhydrinate during pregnancy is contraindicated.

Breastfeeding
Small amounts of dimenhydrinate pass into breast milk. Due to the potential adverse effects of the product in newborns, the use of dimenhydrinate during breastfeeding is contraindicated.

Driving and use of machines
The use of this medicine may cause sedation and drowsiness. In such cases, your ability to drive vehicles or operate machinery may be impaired.

NOVAGO contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take NOVAGO

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.

Use in adults and adolescents (aged 13 to 18 years)
The recommended dose is 1 tablet taken half an hour before travel. If necessary, the dose may be repeated after 3–4 hours, up to a maximum of 4 tablets in 24 hours.

Use in children (aged 6 to 12 years)
The recommended dose is half a tablet taken half an hour before travel. If necessary, the dose may be repeated after 6–8 hours, up to a maximum of 2 tablets (4 half tablets) within 24 hours.
The tablets have a break line which makes them easy to divide into two halves.

If you take more NOVAGO than you should
In case of overdose with this medicine, you may experience sedation ranging from mild drowsiness to deep sleep.
Psychiatric disturbances (psychotic symptoms) have been reported.
In children, excitatory states, insomnia, nervousness, sensation of rapid heartbeat (tachycardia), tremors, muscle disorders (myoclonus), and seizures may occur.
Treatment of overdose includes gastric lavage if not much time has passed since ingestion of the medicine.
If a marked decrease in blood pressure (severe hypotension) occurs, intravenous dextran 70 (intravenous infusion) should be administered. Appropriate symptomatic therapy may also be necessary.
If you or someone else has taken an excessive dose of this medicine, contact a doctor immediately or go to the nearest hospital.

If you forget to take NOVAGO
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Very common (may affect more than 1 in 10 people)

• drowsiness;
• sedation.

Common (may affect up to 1 in 10 people)

• skin disorders (skin reactions);
• loss of appetite;
• headache (cephalalgia);
• visual disturbances (accommodation disorders);
• dry mouth;
• nausea;
• skin sensitivity to light (photosensitivity);
• allergic skin reactions;
• urinary disorders.

Uncommon (may affect up to 1 in 100 people)

• insomnia, especially in children;
• dizziness;
• tremors;
• seizures;
• sensation of rapid heartbeat (tachycardia);
• decrease in blood pressure (hypotension);
• feeling of marked tiredness (asthenia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NOVAGO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 NOVAGO contains

• The active substance is dimenhydrinate. Each tablet contains 50 mg of dimenhydrinate.
• The other components are corn starch, monohydrate lactose, talc, magnesium stearate.

Description of the appearance of NOVAGO and contents of the pack
Pack size: 10 tablets in PVC/Al blister.
Marketing Authorization Holder
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via Carlo Porta, 49 - Gorgonzola - Milano
Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via G. Pascoli, 1 - Gorgonzola - Milano