Cernitol Novum

Document: Cernitol Novum film-coated tablet OTC ENG PL change

Package leaflet: Information for the user

Cernitol Novum film coated tablet

Extracts of pollen from Rye, Timothy and Maize

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you.

Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse after 6 months.

What is in this leaflet

1. What Cernitol Novum is and what it is used for

2. What you need to know before you use Cernitol Novum.

3. How to use Cernitol Novum.

4. Possible side effects.

5. How to store Cernitol Novum.

6. Contents of the pack and other information.

What Cernitol Novum is and what it is used for

Cernitol Novum is a herbal medicinal product for the treatment of symptoms related to benign prostatic hyperplasia (BPH) e.g. frequent need to urinate and nocturia.

What you need to know before you use Cernitol Novum

Do not use Cernitol Novum:

- if you are allergic to extracts of pollen from rye, timothy and maize or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Cernitol Novum to rule out any serious, underlying disease such as cancer of the prostate or urinary bladder.
If the symptoms get worse or persist after 6 months you should contact a doctor for a new assessment. Also, if new symptoms occur, a doctor should be consulted.
If you are going to take a test called ”PSA”, make sure you tell the doctor or nurse that you are using Cernitol Novum, since the result of the test may be compromised.

Children and adolescents

There is no relevant use of Cernitol Novum in children and adolescents.

Other medicines and Cernitol Novum

If you see a doctor, remember to tell him/her that you are taking or have recently taken this OTC medicine.

Cernitol Novum with food, drink and alcohol

There are no studies of interaction between Cernitol Novum and food, drink or alcohol.

Pregnancy, breast-feeding and fertility

There is no relevant use for women.

Possible effects of Cernitol Novum on male fertility have not been studied.

Driving and using machines

Cernitol Novum has no or negligible influence on the ability to drive and use machines.

How to use Cernitol Novum

Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults and elderly men: The recommended dose is 1 film coated tablet 3 times daily. The tablets should be swallowed whole with liquid.

The effect of Cernitol Novum is achieved gradually and it may take up to three months to achieve full effect. The treatment should be continued to maintain the effect.

There is no relevant use of Cernitol Novum for women, adolescents and children.

If you use more Cernitol Novum than you should

If you have taken too much of this medicine, or if a child has taken the medicine by mistake, contact your local doctor or hospital for a risk assessment and to get advise.

If you forget to use Cernitol Novum

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Rare cases of nausea, diarrhoea and hypersensitivity such as rash have been reported

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

5. How to store Cernitol Novum

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 and carton after Exp. The expiry date refers to 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. Contents of the pack and other information

What Cernitol Novum contains

The active substances in 1 film coated tablet are:

40 mg dry extract of dried crude pollen from Secale cereale L. (rye), Phleum pratense L. (timothy) och Zea mays L. (maize) in the ratio 30:1.5:1.
Extraction solvent: water:acetone:sodium laurilsulphate (96:4:0.022 m/m/m).

6.6 mg soft extract of dried crude pollen from Secale cereale L. (rye), Phleum pratense L. (timothy) och Zea mays L. (maize) in the ratio 30:1.5:1.

First extraction solvent: water:acetone:sodium laurilsulphate (96:4:0.022 m/m/m).
Second extraction solvent: acetone.

The other ingredients are microcrystalline cellulose, maltodextrin, croscarmellose sodium, silica, polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.

What Cernitol Novum looks like and contents of the pack

Cernitol Novum are white, oval film-coated tablets.

Cernitol Novum are packed in plastic bottles with 150 or 300 tablets each.

Marketing Authorisation Holder and Manufacturer

AB Cernelle

Höganäsvägen 365

SE-262 94 Ängelholm

Sweden

E-mail: info@cernelle.se

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: CERNITOL NOVUM filmtabletten

France: CERNITOL 47 mg, comprimé pelliculé

Sweden: Cernitol Novum

This leaflet was last revised in 2016-06-15.